The Healthcare Group Laboratories, Inc.: FDA clearances and approvals
The Healthcare Group Laboratories, Inc. has 29 FDA 510(k) clearances (first 1980, latest 1985), across 15 product codes in 8 review panels. Median 510(k) review time: 22 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 | 4 |
| KOD | Catheter, Urological | 4 | 4 |
| FCE | Enema Kit | 3 | 3 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 3 | 3 |
| KPE | Container, I.V. | 3 | 3 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| KQT | Evacuator, Gastro-Urology | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EYN | Tray, Irrigation, Sterile | 1 | 1 |
Plus 5 more product codes.
Review panels
- Gastroenterology and Urology (15)
- General Hospital (4)
- Obstetrics and Gynecology (3)
- General and Plastic Surgery (2)
- Cardiovascular (1)
- Dental (1)
- Orthopedic (1)
- Physical Medicine (1)
Most recent The Healthcare Group Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850035 | EMPTY SOLUTION TRANSFER CONTAINER | KPE | 1985-06-07 | 151 |
| K842170 | EMPTY SOLUTION TRANSFER CONTAINER | KPE | 1984-10-19 | 148 |
| K842091 | DISPOS. ACU-CUT SOFT TISSUE BIOPSY | — | 1984-07-23 | 60 |
| K840742 | RIGHT ATRIAL CATHETER | LJS | 1984-07-13 | 161 |
| K830299 | SOLUTION TRANSFER CONTAINER | KPE | 1983-02-19 | 22 |
| K822307 | ADHESIVE SPRAY #4050-4060 | KNX | 1982-09-24 | 52 |
| K822059 | SHOW'RBAG | LGF | 1982-07-22 | 9 |
| K821480 | RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT | DQY | 1982-06-17 | 30 |
| K821230 | SOFTIC 49 | EBI | 1982-05-28 | 31 |
| K821162 | ADHESIVE REMOVER | KOX | 1982-05-14 | 18 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Healthcare Group Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances does The Healthcare Group Laboratories, Inc. have?
The Healthcare Group Laboratories, Inc. has 29 FDA 510(k) clearances (first 1980, latest 1985), across 15 product codes in 8 review panels.
How long does FDA take to clear The Healthcare Group Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across The Healthcare Group Laboratories, Inc.'s cleared 510(k)s is 22 days.
What devices does The Healthcare Group Laboratories, Inc. make?
Its most frequent FDA product codes are KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 4); KOD (Catheter, Urological, 4); FCE (Enema Kit, 3).
Has The Healthcare Group Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Healthcare Group Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 29 The Healthcare Group Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNX, The Healthcare Group Laboratories, 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.