AMT Initial Placement Dilator Set
AMT Initial Placement Dilator Kit (Smaller Dia GW)
25manufacturers in China registered for this device type
5catalogue 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) | K073034 |
| Record published | 2024-08-23 |
| Record revised | 2024-12-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IP-DIL-10 | 10 Fr | In distribution |
| IP-DIL | In distribution | |
| IP-DIL-10 | 10 Fr | In distribution |
| IP-DIL | In distribution | |
| IP-DIL | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Applied Medical Technology, Inc. | 510(k) number | 2024-05-14 | Class II | Process control | Devices were labelled with the incorrect guidewire labelling. | 74 units |
Recalls
10 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 | |
| 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.