Applied Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Applied Medical Technology, Inc.” (first 1998, latest 2026), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 140 days. Since 2017 the median was 150 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 88 |
| 2013 | 1 | 136 |
| 2014 | 1 | 253 |
| 2015 | 3 | 151 |
| 2016 | 0 | — |
| 2017 | 2 | 254 |
| 2018 | 1 | 149 |
| 2019 | 2 | 126 |
| 2020 | 2 | 67 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 453 |
| 2024 | 2 | 164 |
| 2025 | 0 | — |
| 2026 | 1 | 186 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Applied Medical Technology, Inc. took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 16 | 16 |
| KGC | Tube, Gastro-Enterostomy | 3 | 3 |
| CBH | Device, Fixation, Tracheal Tube | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 1 | 1 |
| PIO | Enteral Specific Transition Connectors | 1 | 1 |
| QVS | Breast Implant Suction Retrieval Device | 1 | 1 |
Review panels
Most recent Applied Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252438 | Explant Express | QVS | 2026-02-03 | 186 |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | KOB | 2024-11-01 | 253 |
| K241111 | AMT Suture Passer | GCJ | 2024-07-05 | 74 |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | KNT | 2023-12-18 | 453 |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | KNT | 2020-10-29 | 57 |
| K193612 | AMT Suture Delivery System | KGC | 2020-03-12 | 77 |
| K183508 | Micro Transgastric-Jejunal Feeding Device | KNT | 2019-03-29 | 101 |
| K182804 | Traditional Length GJ Feeding Device | KNT | 2019-03-01 | 150 |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | KNT | 2018-06-01 | 149 |
| K170319 | Low Profile Non-Balloon Feeding Device | KNT | 2017-10-06 | 247 |
15 earlier clearances. See the full list in Caduvo.
Recalls
19 product recalls in 8 recall events; 11 initiated in the last five years. Most recent: 2025-10-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Spectral Imaging , Ltd. (8 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Medical Technology, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Applied Medical Technology, Inc.” (first 1998, latest 2026), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Applied Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Medical Technology, Inc. is 140 days. Since 2017: 150 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Applied Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 16); KGC (Tube, Gastro-Enterostomy, 3); CBH (Device, Fixation, Tracheal Tube, 1).
Next steps
- See all 25 Applied Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Applied Medical Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.