Continental Medical Laboratories, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Continental Medical Laboratories, Inc.” (first 1991, latest 1997), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| GDT | Staple, Removable (Skin) | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MCY | Wound Dressing Kit | 1 | 1 |
| MCZ | Suture Removal Kit | 1 | 1 |
Review panels
- General and Plastic Surgery (5)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Continental Medical Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964827 | PROD. NO. 01-132 - SUTURE REMOVAL KIT | MCZ | 1997-02-14 | 74 |
| K963234 | STAPLE REMOVAL KIT | GDT | 1996-10-21 | 63 |
| K963443 | PROD. NO. 02-031 - LACERATION TRAY | LRO | 1996-10-17 | 48 |
| K962078 | TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER | JOH | 1996-10-11 | 136 |
| K954728 | PROD NO. 01-1694 - 4X4 FOAM DRESSING | KMF | 1996-09-23 | 346 |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | FCM | 1996-06-21 | 24 |
| K952335 | WOUND CARE MANAGEMENT KITS | LYY | 1995-06-14 | 27 |
| K905123 | G-TUBE DRESSING CHANGE TRAY | MCY | 1991-03-27 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Continental Medical 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.
- Continental X-Ray Corp. (27 510(k)s)
- Continental Optical Imports (2 510(k)s)
- Continental Soft Lens, Inc. (2 510(k)s)
- Continental Dental Ceramics, Inc. (1 510(k)s)
- Continental Dental Ceramics, Inc. (Dba Continental (1 510(k)s)
- Continental Dental Laboratory (1 510(k)s)
- Continental Products, Inc. (1 510(k)s)
- Continental Scale Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Continental Medical Laboratories, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Continental Medical Laboratories, Inc.” (first 1991, latest 1997), across 8 product codes in 4 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 Continental Medical Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Continental Medical Laboratories, Inc. is 68 days.
Which FDA product codes appear under Continental Medical Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 1); GDT (Staple, Removable (Skin), 1); JOH (Tube Tracheostomy And Tube Cuff, 1).
Next steps
- See all 8 Continental Medical Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FCM, Continental Medical 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.