Device Labs, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Device Labs, Inc.” (first 1988, latest 1993), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Device Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930632 | CHEMOSITE IMPLANTABLE DRUG DELIVERY | KMF | 1993-12-22 | 317 |
| K904417 | CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM | LJT | 1990-12-05 | 69 |
| K902135 | PERCUTANEOUS INTRODUCER KIT | FOZ | 1990-08-01 | 83 |
| K901722 | CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM | LJT | 1990-07-03 | 78 |
| K883764 | INTRAVASCULAR ADMINISTRATION SET | FPA | 1988-12-19 | 104 |
| K882064 | LO-CORE NEEDLE | FMI | 1988-07-08 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Device Labs, 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.
- Device Partners International (1 510(k)s)
- Device Resources (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Device Labs, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Device Labs, Inc.” (first 1988, latest 1993), across 5 product codes in 2 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 Device Labs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Device Labs, Inc. is 80 days.
Which FDA product codes appear under Device Labs, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 2); FMI (Needle, Hypodermic, Single Lumen, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 6 Device Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Device Labs, 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.