Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Medical Technology, Inc. · Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
262 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252438 | Explant Express | Applied Medical Technology, Inc. | 2026-02-03 | 186 | 0 |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024-11-01 | 253 | 0 |
| K241111 | AMT Suture Passer | Applied Medical Technology, Inc. | 2024-07-05 | 74 | 0 |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023-12-18 | 453 | 0 |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | Applied Medical Technology, Inc. | 2020-10-29 | 57 | 6 |
| K193612 | AMT Suture Delivery System | Applied Medical Technology, Inc. | 2020-03-12 | 77 | 0 |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 2019-03-29 | 101 | 0 |
| K182804 | Traditional Length GJ Feeding Device | Applied Medical Technology, Inc. | 2019-03-01 | 150 | 0 |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | Applied Medical Technology, Inc. | 2018-06-01 | 149 | 0 |
| K170319 | Low Profile Non-Balloon Feeding Device | Applied Medical Technology, Inc. | 2017-10-06 | 247 | 0 |
| K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017-02-09 | 262 | 0 |
| K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | 2015-06-09 | 151 | 0 |
| K142971 | AMT Bridle - Nasal Tube Retention System | Applied Medical Technology, Inc. | 2015-05-26 | 224 | 2 |
| K142989 | Mini ONE Enteral Extension Set | Applied Medical Technology, Inc. | 2015-01-29 | 105 | 1 |
| K140097 | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | Applied Medical Technology, Inc. | 2014-09-24 | 253 | 0 |
| K123716 | AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT | Applied Medical Technology, Inc. | 2013-04-19 | 136 | 0 |
| K120587 | AMT T-FASTENER ANCHOR KIT | Applied Medical Technology, Inc. | 2012-05-25 | 88 | 0 |
| K110804 | AMT G-J TUBE | Applied Medical Technology, Inc. | 2011-10-19 | 211 | 0 |
| K073034 | AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2 | Applied Medical Technology, Inc. | 2008-03-14 | 140 | 1 |
| K043027 | MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 | Applied Medical Technology, Inc. | 2004-12-02 | 29 | 0 |
| K042300 | AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM | Applied Medical Technology, Inc. | 2004-10-25 | 62 | 0 |
| K030784 | NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL | Applied Medical Technology, Inc. | 2004-04-01 | 386 | 2 |
| K012476 | MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 | Applied Medical Technology, Inc. | 2001-08-31 | 29 | 0 |
| K980305 | AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE | Applied Medical Technology, Inc. | 1998-04-16 | 79 | 0 |
| K980145 | AMT DECOMPRESSION TUBES | Applied Medical Technology, Inc. | 1998-04-10 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda