Northeast Scientific, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Northeast Scientific, Inc.” (first 2007, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 137 days, against 94 days for all cleared 510(k)s in the same product codes. 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 | 1 | 147 |
| 2021 | 0 | — |
| 2022 | 1 | 161 |
| 2023 | 1 | 127 |
| 2024 | 0 | — |
| 2025 | 1 | 74 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Northeast Scientific, Inc. took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 2 | 2 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 1 | 1 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 1 | 1 |
| OBJ | Catheter, Ultrasound, Intravascular | 1 | 1 |
| QTF | Reprocessed Atherectomy Catheter | 1 | 1 |
Review panels
Most recent Northeast Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | OWQ | 2025-05-12 | 74 |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | 2023-02-03 | 127 |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | QTF | 2022-07-01 | 161 |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | OBJ | 2020-06-22 | 147 |
| K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER | NUJ | 2010-07-21 | 496 |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | NLM | 2007-09-07 | 542 |
Recalls
9 product recalls in 2 recall events; 8 initiated in the last five years. Most recent: 2025-08-29.
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.
- Northeast Biomedical Labs., Inc. (9 510(k)s)
- Northeast Iowa Podiatry (1 510(k)s)
- Northeast Orthotics and Prothetics, Inc. (1 510(k)s)
- Northeast Resins & Silicones, LLC (1 510(k)s)
- Northeast Scientific, Inc. (Nes) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Northeast Scientific, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Northeast Scientific, Inc.” (first 2007, latest 2025), across 5 product codes in 3 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 Northeast Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Northeast Scientific, Inc. is 154 days. Since 2017: 137 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Northeast Scientific, Inc.?
The most frequent FDA product codes under this applicant name are OWQ (Reprocessed Intravascular Ultrasound Catheter, 2); NLM (Laparoscope, General & Plastic Surgery, Reprocessed, 1); NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, 1).
Next steps
- See all 6 Northeast Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OWQ, Northeast Scientific, 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.