Who else makes this device?

Name: Agile Test
Brand: Agile Test

Agile Test · Ventilator, Continuous, Facility Use → Anesthesiology

8manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CBK
Manufacturer	City	Province	Registered as	Device types
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Beijing Aeonmed Co., Ltd.	Sanhe	Hebei	Contract manufacturer	7
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Agile Test
Listed by	Zoll Medical Corporation, United States
FDA product code	CBK
Device type	Ventilator, Continuous, Facility Use
Device class	Class 2
Regulation	21 CFR 868.5895
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K111473
Record published	2019-01-30
Record revised	2026-02-11 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Storage	Storage environment atmospheric pressure from 0 KiloPascal; Handling environment temperature 0 to 0 °C; Storage environment humidity 0 to 0 % RH; Storage environment temperature 0 to 0 °C
Distribution end date	2026-01-01

Catalogue Numbers

Catalogue numbers for Agile Test
Catalogue number	Size	Status
TEST 8.6		Withdrawn
TEST 8.6.A		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Puritan Bennett	Covidien LP	285
Newport	Newport Medical Instruments, Inc.	103
LTV	Vyaire Medical, Inc.	92
Ventilator, Continuous, Facility Use	Hans Rudolph, Inc.	66
Infant Flow SiPAP	Carefusion	62
Avea	Carefusion	57
Ventoux	Flight Medical Innovations Ltd.	48
Trilogy	Respironics Inc.	42
Avea™	Vyaire Medical, Inc.	39
Patient Circuits	Zoll Medical Corporation	38
Performatrak	Respironics Inc.	35
Bio-Med Devices, Inc.	BIO-MED Devices, Inc.	34

Showing 12 of 419. All products under Ventilator, Continuous, Facility Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233486	2024-12-13
K162832	2017-08-02

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Agile Test
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Zoll Medical Corporation	510(k) number	2024-04-30	Class I	Under Investigation by firm	Operator’s Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure prope	2361 units
Zoll Medical Corporation	510(k) number	2017-06-30	Class II	Under Investigation by firm	A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.	46	2018-10-09

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-03-19	Class III	Process control	Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.	Ten Units	2012-08-15

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.

Agile Test