The Healthcare Group Laboratories, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “The Healthcare Group Laboratories, Inc.” (first 1980, latest 1985), across 15 product codes in 8 review panels. Median 510(k) review time under this name: 22 days. 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 | 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 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.
- Healthcare Service and Supply (4 510(k)s)
- Healthcare Gloves Sdn Bhd (2 510(k)s)
- The Healthcare Group, Inc. (2 510(k)s)
- Healthcare Ind. (2 510(k)s)
- Healthcare Technologies, Inc. (2 510(k)s)
- Healthcare Designs (1 510(k)s)
- Healthcare Enterprises, Inc. (1 510(k)s)
- Healthcare Innovations, LLC (1 510(k)s)
- Healthcare Management Systems (1 510(k)s)
- Healthcare Suppliers, Inc. (1 510(k)s)
- Healthcare Technologies Resources, Inc. (1 510(k)s)
- Healthcare Vision, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Healthcare Group Laboratories, Inc.?
FDA lists 29 510(k) clearances under the applicant name “The Healthcare Group Laboratories, Inc.” (first 1980, latest 1985), across 15 product codes in 8 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 The Healthcare Group Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Healthcare Group Laboratories, Inc. is 22 days.
Which FDA product codes appear under The Healthcare Group Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 4); KOD (Catheter, Urological, 4); FCE (Enema Kit, 3).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.