American Healthcare Corp.: FDA clearances and approvals
American Healthcare Corp. has 17 FDA 510(k) clearances (first 1986, latest 2005), across 9 product codes in 5 review panels. Median 510(k) review time: 139 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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 5 | 5 |
| EYN | Tray, Irrigation, Sterile | 4 | 4 |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| HHD | Pad, Menstrual, Unscented | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Review panels
- General and Plastic Surgery (7)
- Anesthesiology (5)
- Clinical Chemistry (3)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent American Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043543 | BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2005-04-08 | 109 |
| K043512 | EASYGLUCO IGM-0002 G2 | CGA | 2005-04-08 | 109 |
| K031501 | EASYGLUCO, MODEL IGM0002 | NBW | 2003-10-16 | 156 |
| K924192 | I.V. START KIT (AHC-50-54954 | KGX | 1993-08-27 | 372 |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | EYN | 1993-06-17 | 316 |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | EYN | 1993-06-17 | 316 |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | EYN | 1993-06-17 | 316 |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | EYN | 1993-06-17 | 316 |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | BTO | 1993-06-16 | 300 |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | BTO | 1993-04-02 | 225 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Healthcare Corp..
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 American Healthcare Corp. have?
American Healthcare Corp. has 17 FDA 510(k) clearances (first 1986, latest 2005), across 9 product codes in 5 review panels.
How long does FDA take to clear American Healthcare Corp.'s 510(k)s?
The median time from FDA receipt to decision across American Healthcare Corp.'s cleared 510(k)s is 139 days.
What devices does American Healthcare Corp. make?
Its most frequent FDA product codes are BTO (Tube, Tracheostomy (W/Wo Connector), 5); EYN (Tray, Irrigation, Sterile, 4); NBW (System, Test, Blood Glucose, Over The Counter, 2).
Has American Healthcare Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Healthcare Corp. Related entities may recall under other names.
Next steps
- See all 17 American Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTO, American Healthcare Corp.'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.