Harvard Apparatus, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Harvard Apparatus, Inc.” (first 1978, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 6 | 6 |
| FLE | Sterilizer, Steam | 2 | 2 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
Review panels
- General Hospital (9)
Most recent Harvard Apparatus, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970678 | THE HARVARD LIBRARY | MRZ | 1998-01-09 | 319 |
| K952794 | HARVARD 2 SYRINGE PUMP | FRN | 1995-09-15 | 88 |
| K903614 | HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE | FLE | 1990-12-14 | 127 |
| K903613 | HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) | FLE | 1990-11-07 | 90 |
| K813644 | MODEL 2650 HIGH CAPACITY DUAL SYRINGE | FRN | 1982-02-18 | 49 |
| K801904 | SYRINGE INFUSION PUMP #2716 | FRN | 1980-08-27 | 16 |
| K800569 | SYRINGE INFUSION PUMP #2720 | FRN | 1980-04-08 | 25 |
| K791293 | BATTERY POWERED SYRINGE INFUSION PUMP | FRN | 1979-11-13 | 126 |
| K780705 | INFUSION PUMP-MODEL 2616 | FRN | 1978-05-19 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Harvard Apparatus, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Harvard Apparatus, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Laboratories (8 510(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 Apparatus, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Harvard Apparatus, Inc.” (first 1978, latest 1998), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Harvard Apparatus, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harvard Apparatus, Inc. is 88 days.
Which FDA product codes appear under Harvard Apparatus, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 6); FLE (Sterilizer, Steam, 2); MRZ (Accessories, Pump, Infusion, 1).
Next steps
- See all 9 Harvard Apparatus, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Harvard Apparatus, 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.