FDA applicant
Northeast Scientific, Inc.
FDA records 6 decisions for Northeast Scientific, Inc. (Waterbury, CT) from 2007 to 2025: 6 510(k) clearances. Most are in product codes OWQ (Reprocessed Intravascular Ultrasound Catheter) and NLM (Laparoscope, General & Plastic Surgery…). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Northeast Scientific, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Northeast Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Northeast”
FDA records each applicant name separately; these may or may not be the same firm.