Applied Medical Technologies: FDA clearances and approvals
Applied Medical Technologies has 24 FDA 510(k) clearances (first 1981, latest 1998), across 13 product codes in 4 review panels. Median 510(k) review time: 81 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 10 | 10 |
| KGC | Tube, Gastro-Enterostomy | 3 | 3 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GAB | Needle, Suturing, Disposable | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 | 1 |
| GDX | Scalpel, One-Piece | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HRQ | Hemostat | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (13)
- General and Plastic Surgery (9)
- Clinical Chemistry (1)
- General Hospital (1)
Most recent Applied Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971434 | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE | KNT | 1998-08-17 | 486 |
| K972478 | PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES | KNT | 1998-02-09 | 223 |
| K973893 | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE | KNT | 1997-12-19 | 66 |
| K971757 | LOW PROFILE FEEDING SET ACCESSORY | KNT | 1997-11-07 | 178 |
| K971758 | CAUTERIZATION SMOKE EVACUATOR | GEI | 1997-07-21 | 69 |
| K961345 | DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE | KNT | 1996-09-17 | 162 |
| K960232 | ENDOSCOPIC ACCESS DEVICE | GCJ | 1996-03-21 | 64 |
| K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | KNT | 1995-10-12 | 331 |
| K946140 | PRG BUTTON | KNT | 1995-08-28 | 255 |
| K923488 | GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY | KNT | 1995-07-20 | 1100 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Medical Technologies.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Applied Medical Technologies have?
Applied Medical Technologies has 24 FDA 510(k) clearances (first 1981, latest 1998), across 13 product codes in 4 review panels.
How long does FDA take to clear Applied Medical Technologies's 510(k)s?
The median time from FDA receipt to decision across Applied Medical Technologies's cleared 510(k)s is 81 days.
What devices does Applied Medical Technologies make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 10); KGC (Tube, Gastro-Enterostomy, 3); FPA (Set, Administration, Intravascular, 1).
Has Applied Medical Technologies had device recalls?
openFDA lists no recalls under a recalling firm name matching Applied Medical Technologies. Related entities may recall under other names.
Next steps
- See all 24 Applied Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code KNT, Applied Medical Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.