American Medical Products, Inc.: FDA clearances and approvals
American Medical Products, Inc. has 30 FDA 510(k) clearances (first 1978, latest 1992), across 11 product codes in 5 review panels. Median 510(k) review time: 50 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | 11 | 11 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 7 | 7 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | 3 | 3 |
| FRN | Pump, Infusion | 2 | 2 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 1 | 1 |
| FKK | Clamp, Line | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (24)
- Cardiovascular (2)
- General Hospital (2)
- Clinical Chemistry (1)
- General and Plastic Surgery (1)
Most recent American Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922290 | SINGLE-STEP PREGNANCY, HCG TEST | JHI | 1992-07-09 | 55 |
| K862221 | E-Z CLEAN | GEI | 1986-09-12 | 93 |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | KNX | 1986-04-17 | 15 |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | FKX | 1983-06-02 | 76 |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | FKX | 1983-03-17 | 87 |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | FKK | 1982-10-13 | 50 |
| K822550 | SAFE LOCK TITANIUM ADAPTER SET | FKX | 1982-10-13 | 50 |
| K822549 | CCPD CYCLER SET W/5 PRONGED SAFE LOCK | FKX | 1982-10-13 | 50 |
| K822548 | SAFE LOCK CATHETER S-3 | FKX | 1982-10-13 | 50 |
| K822546 | SAFE LOCK SEALING CAPS | FKX | 1982-10-13 | 50 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Medical Products, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of American Medical Products, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does American Medical Products, Inc. have?
American Medical Products, Inc. has 30 FDA 510(k) clearances (first 1978, latest 1992), across 11 product codes in 5 review panels.
How long does FDA take to clear American Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across American Medical Products, Inc.'s cleared 510(k)s is 50 days.
What devices does American Medical Products, Inc. make?
Its most frequent FDA product codes are FKX (System, Peritoneal, Automatic Delivery, 11); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 7); KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal, 3).
Has American Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 30 American Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FKX, American Medical Products, Inc.'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.