Harvard Laboratories: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Harvard Laboratories” (first 1980, latest 1982), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| FPK | Tubing, Fluid Delivery | 2 | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Harvard Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | FAM | 1982-11-17 | 64 |
| K810573 | TUBE FEEDING SET | KNT | 1981-04-23 | 51 |
| K810574 | SUCTION COLLECTION BOTTLE, DISPOSABLE | KDQ | 1981-04-21 | 49 |
| K800879 | CLEAR PLASTIC CONNECTING TUBES | FPK | 1980-06-17 | 61 |
| K800878 | SECONDARY I.V. TUBING SETS | FPA | 1980-06-17 | 61 |
| K800877 | ANESTHESIA EXTENSION TUBES | FPK | 1980-06-17 | 61 |
| K800880 | PLASTIC TUBING ADAPTERS 5-IN-1- | DTL | 1980-05-14 | 27 |
| K800881 | DISPOSABLE BERMAN AIRWAYS | CAE | 1980-05-08 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Harvard Laboratories.
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.
- Harvard Apparatus, Inc. (9 510(k)s)
- Harvard Medical Devices , Ltd. (5 510(k)s)
- Harvard Clinical Technology (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Harvard Laboratories?
FDA lists 8 510(k) clearances under the applicant name “Harvard Laboratories” (first 1980, latest 1982), across 7 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 Harvard Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harvard Laboratories is 56 days.
Which FDA product codes appear under Harvard Laboratories?
The most frequent FDA product codes under this applicant name are FPK (Tubing, Fluid Delivery, 2); CAE (Airway, Oropharyngeal, Anesthesiology, 1); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 1).
Next steps
- See all 8 Harvard Laboratories clearances with predicates and recalls
- Run predicate analysis for product code FPK, Harvard Laboratories'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.