Mini Balloon Button
14FR x 5.5 cm MINI Balloon Button Kit (ENFit), MDR
25manufacturers in China registered for this device type
62catalogue numbers in this listing
26510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | Applied Medical Technology, Inc., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K161413 |
| Record published | 2026-04-09 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 0.8 to 6 cm; catheter gauge 12 to 24 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5-1455-I | Length 5.5 cm | In distribution |
| 5-1217-I | Length 1.7 cm | In distribution |
| 5-1435-I | Length 3.5 cm | In distribution |
| 5-2030 | Catheter Gauge 20 Fr | In distribution |
| 5-1220 | Catheter Gauge 12 Fr | In distribution |
| 5-1217 | Length 1.7 cm | In distribution |
| 5-1412 | Length 1.2 cm | In distribution |
| 5-1444-I | Length 4.4 cm | In distribution |
| 5-1427-I | Length 2.7 cm | In distribution |
| 5-1623-I | Length 2.3 cm | In distribution |
| 5-1240 | Catheter Gauge 12 Fr | In distribution |
| 5-1208 | Catheter Gauge 12 Fr | In distribution |
| 5-1860-I | Length 6.0 cm | In distribution |
| 5-1620-I | Catheter Gauge 16 Fr | In distribution |
| 5-1225-I | Catheter Gauge 12 Fr | In distribution |
| 5-1620 | Catheter Gauge 16 Fr | In distribution |
| 5-1430 | Catheter Gauge 14 Fr | In distribution |
| 5-2427-I | Length 2.7 cm | In distribution |
| 5-1415-I | Catheter Gauge 14 Fr | In distribution |
| 5-1415 | Catheter Gauge 14 Fr | In distribution |
| 5-1425 | Catheter Gauge 14 Fr | In distribution |
| 5-1235 | Length 3.5 cm | In distribution |
| 5-1215 | Catheter Gauge 12 Fr | In distribution |
| 5-1860 | Length 6.0 cm | In distribution |
| 5-1420-I | Catheter Gauge 14 Fr | In distribution |
| 5-1408-I | Length 0.8 cm | In distribution |
| 5-1240-I | Catheter Gauge 12 Fr | In distribution |
| 5-1440-I | Catheter Gauge 14 Fr | In distribution |
| 5-1423-I | Length 2.3 cm | In distribution |
| 5-1410-I | Catheter Gauge 14 Fr | In distribution |
| 5-1427 | Length 2.7 cm | In distribution |
| 5-1212 | Length 1.2 cm | In distribution |
| 5-1423 | Length 2.3 cm | In distribution |
| 5-1235-I | Length 3.5 cm | In distribution |
| 5-1208-I | Catheter Gauge 12 Fr | In distribution |
| 5-1410 | Catheter Gauge 14 Fr | In distribution |
| 5-1623 | Length 2.3 cm | In distribution |
| 5-1450 | Catheter Gauge 14 Fr | In distribution |
| 5-1230-I | Catheter Gauge 12 Fr | In distribution |
| 5-1223 | Length 2.3 cm | In distribution |
| 5-1430-I | Catheter Gauge 14 Fr | In distribution |
| 5-1455 | Length 5.5 cm | In distribution |
| 5-1408 | Length 0.8 cm | In distribution |
| 5-1440 | Catheter Gauge 14 Fr | In distribution |
| 5-1223-I | Length 2.3 cm | In distribution |
| 5-1225 | Catheter Gauge 12 Fr | In distribution |
| 5-1220-I | Catheter Gauge 12 Fr | In distribution |
| 5-1417-I | Length 1.7 cm | In distribution |
| 5-1412-I | Length 1.2 cm | In distribution |
| 5-2030-I | Catheter Gauge 20 Fr | In distribution |
| 5-1212-I | Length 1.2 cm | In distribution |
| 5-1227 | Length 2.7 cm | In distribution |
| 5-1450-I | Catheter Gauge 14 Fr | In distribution |
| 5-1417 | Length 1.7 cm | In distribution |
| 5-1230 | Catheter Gauge 12 Fr | In distribution |
| 5-1435 | Length 3.5 cm | In distribution |
| 5-1425-I | Catheter Gauge 14 Fr | In distribution |
| 5-1444 | Length 4.4 cm | In distribution |
| 5-1215-I | Catheter Gauge 12 Fr | In distribution |
| 5-1420 | Catheter Gauge 14 Fr | In distribution |
| 5-2427 | Length 2.7 cm | In distribution |
| 5-1227-I | Length 2.7 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222846 | 2023-12-18 |
| K202539 | 2020-10-29 |
| K183508 | 2019-03-29 |
| K182804 | 2019-03-01 |
| K180026 | 2018-06-01 |
| K170319 | 2017-10-06 |
| K161413 | 2017-02-09 |
| K142971 | 2015-05-26 |
| K123716 | 2013-04-19 |
| K110804 | 2011-10-19 |
| K073034 | 2008-03-14 |
| K043027 | 2004-12-02 |
| K042300 | 2004-10-25 |
| K030784 | 2004-04-01 |
| K012476 | 2001-08-31 |
| K971434 | 1998-08-17 |
| K980305 | 1998-04-16 |
| K972478 | 1998-02-09 |
| K973893 | 1997-12-19 |
| K971757 | 1997-11-07 |
| K961345 | 1996-09-17 |
| K945618 | 1995-10-12 |
| K946140 | 1995-08-28 |
| K923488 | 1995-07-20 |
| K923692 | 1993-05-07 |
| K920894 | 1992-04-28 |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | ||
| 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | ||
| 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | ||
| 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | ||
| 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | ||
| 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 840 units | |
| 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 200 units | |
| 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 390 units | |
| 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 1780 units | |
| 2024-05-14 | Class II | Process control | Devices were labelled with the incorrect guidewire labelling. | 74 units | |
| 2017-01-19 | Class III | Employee error | Expired expiration dates are listed on the pouches. | 110 | 2017-12-15 |
| 2017-01-19 | Class III | Employee error | Expired expiration dates are listed on the pouches. | 110 | 2017-12-15 |
| 2016-01-26 | Class II | Employee error | The firm received complaints that the product is shorter in length than indicated on the label. | 20 units | 2016-10-27 |
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.