AF531
AF531 EE LEAK 2, 4 POINT HEADGEAR, SINGLE USE, SMALL AF531 Mask with Entrainment Elbow, Leak 2, 4 Point Headgear, Single Use, Small
6manufacturers in China registered for this device type
53catalogue numbers in this listing
12510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Beijing (1), Tianjin (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BMC (Tianjin) Medical Co., Ltd. | Wuqing District | Tianjin | Contract manufacturer | 3 |
| Huizhou RSP Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| BMC Medical Co., Ltd. | Fengtai District | Beijing | Specification developer | 3 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | MNS |
| Device type | Ventilator, Continuous, Non-Life-Supporting |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-06-10 |
| Record revised | 2024-10-31 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
| Packaging | Multipack of 10, multipack of 5 |
| Distribution end date | 2023-08-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AF531 Mask EE with CapStrap, Large, USA | In distribution | |
| AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use | In distribution | |
| AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use | In distribution | |
| AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use | In distribution | |
| AF531 EE, Leak 1, Neb Elbow, w/4 PT Headgr, SU, Medium, US | In distribution | |
| AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Sm, SU | In distribution | |
| AF531Mask EE, Leak 1, Neb Elbow, 4 PT Headgr, Large, SU | In distribution | |
| AF531 Mask EE (NE) with 4 point Headgear, Large, USA | In distribution | |
| AF531 Mask EE with 4 point Headgear, Large, USA | In distribution | |
| AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU | In distribution | |
| AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Med, SU | In distribution | |
| AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Large, SU | In distribution | |
| AF531 Mask EE, Leak 2, with 4 PT Headgear, Medium, SU | In distribution | |
| AF531 Mask EE (NE) with CapStrap, Small, USA | In distribution | |
| AF531 Mask EE, Leak 2, with 4 PT Headgear, Small, SU | In distribution | |
| AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU | In distribution | |
| AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Med, SU | In distribution | |
| AF531 Mask EE Leak 2 with 4 PT Headgear, Small, Single Use | In distribution | |
| AF531 EE Leak1 NE 4PT Headgear, Single Use,Small, US | In distribution | |
| AF531 Mask EE (NE) with 4 point Headgear, Medium, USA | In distribution | |
| AF531 Mask EE, Leak 2, w/CapStrap, Large, SU | In distribution | |
| A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU | In distribution | |
| AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use | In distribution | |
| AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Med, SU | In distribution | |
| AF531 Mask EE (NE) with 4 point Headgear, Small, USA | In distribution | |
| AF531 Mask EE with 4 point Headgear, Medium, USA | In distribution | |
| AF531 Mask EE, Leak 2, with 4 PT Headgear, Large, SU | In distribution | |
| AF531 Mask EE, LEAK 1, with 4 PT Headgear, Large, Single Use | In distribution | |
| AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Small, SU | In distribution | |
| AF531 EE, Leak 1, Neb Elbow, with CapStrap, SU, Small, US | In distribution | |
| AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Sm, SU | In distribution | |
| AF531 Mask EE, LEAK 1, with CapStrap, Small, Single Use | In distribution | |
| AF531 Mask EE with CapStrap, Small, USA | In distribution | |
| AF531Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, L, SU | In distribution | |
| AF531 Mask EE with 4 PT Headgear, Small, USA | In distribution | |
| A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU | In distribution | |
| A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU | In distribution | |
| AF531 MASK, EE, Leak 1, Neb Elbow, w/CapStrap, SU, Large,US | In distribution | |
| AF531, EE, Leak 1, Neb Elbow, w/4 PT Headgr, SU, Large, US | In distribution | |
| AF531 Mask EE,Leak 1,Circuit, Neb Elbow,Capstrap,SU,Large,US | Withdrawn | |
| AF531 Mask EE, Leak 1 with CapStrap, Large, Single Use | Withdrawn | |
| AF531 Mask EE, Leak 1 w/ CapStrap, Small, Single Use | Withdrawn | |
| AF531 Mask EE, Leak 1 with 4 PT Headgear, Small, SU | Withdrawn | |
| AF531 Mask EE with CapStrap, Medium, USA | Withdrawn | |
| AF531Mask EE,Leak1,Circuit, Neb Elbow,Capstrap, SU, M, US | Withdrawn | |
| AF531 Mask EE (Nebulizing Elbow) with CapStrap, Large, USA | Withdrawn | |
| AF531 Mask EE, Leak 1 with 4 PT Headgear, Large, Single Use | Withdrawn | |
| AF531 Mask EE,Leak 1,Circuit, Neb Elbow,Capstrap, SU, Sm, US | Withdrawn | |
| AF531 Mask EE, Leak 1 with CapStrap, Medium, SU | Withdrawn | |
| AF531 Mask EE (NE) with CapStrap, Medium, USA | Withdrawn | |
| AF531 Mask EE, Leak 2 with 4 PT Headgear, Medium, SU | Withdrawn | |
| AF531 Mask EE, Leak 1 with 4 PT Headgear, Medium, SU | Withdrawn | |
| 00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 144 |
| BiPAP autoSV Advanced System One 60 Series | Respironics Inc. | 44 |
| BiPAP Avaps | Respironics Inc. | 35 |
| DreamStation BiPAP Avaps | Respironics Inc. | 30 |
| DreamMapper | Respironics Inc. | 27 |
| BiPAP A30 | Respironics Inc. | 25 |
| BiPAP S/T C-Series | Respironics Inc. | 19 |
| OmniLab Advanced Plus | Respironics Inc. | 19 |
| EncoreAnywhere | Respironics Inc. | 17 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 15 |
| Ventilator, Continuous, Non-Life-Supporting | Salter Labs | 12 |
| DreamStation BiPAP autoSV | Respironics Inc. | 12 |
Showing 12 of 73. All products under Ventilator, Continuous, Non-Life-Supporting
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113053 | 2012-02-01 |
| K102465 | 2011-03-24 |
| K101130 | 2010-09-02 |
| K092818 | 2010-01-22 |
| K092043 | 2009-08-05 |
| K063540 | 2007-02-22 |
| K063533 | 2007-02-20 |
| K031656 | 2003-07-30 |
| K020777 | 2002-03-20 |
| K012323 | 2001-12-20 |
| K992530 | 2000-03-20 |
| K984407 | 1999-05-19 |
Recalls
15 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-09 | Class I | Device Design | This device does not indicate for use in patients with respiratory failure. | 5,958 units | |
| 2025-05-09 | Class I | Device Design | This device does not indicate for use in patients with respiratory failure. | 3 units in US 22,416 units and 49 units OUS | |
| 2024-04-01 | Class I | Device Design | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death. | 9,388 US; 2,664 ROW | |
| 2024-03-26 | Class I | Device Design | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the | 3 US; 21,414 OUS | |
| 2024-03-26 | Class I | Device Design | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the | 5,958 US; None OUS | |
| 2022-08-26 | Class I | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | 85 units | |
| 2022-08-26 | Class I | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | 34 units ***updated January 2024 *** additional 3 units | |
| 2022-08-26 | Class I | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | 295 units | |
| 2022-08-26 | Class I | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | 1,091 units ***updated Jan 2024*** additional 323 units | |
| 2022-08-26 | Class I | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | 8 units | |
| 2022-08-26 | Class I | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | 146 units ***updated January 2024*** 30 additional units | |
| 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 8047 | |
| 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total | |
| 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total | |
| 2021-06-14 | Class I | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. | 72665 | |
| 2021-04-06 | Class II | Nonconforming Material/Component | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxico | 2 units | 2024-01-17 |
| 2021-04-06 | Class II | Nonconforming Material/Component | Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxico | 22 units | 2024-01-17 |
| 2008-09-22 | Not classified | Component design/selection | Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit’s power supply. A disconnection or interm | 2,270 Power Cords | 2010-07-06 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.