FDA applicant
Sterilmed, Inc.
FDA records 65 decisions for Sterilmed, Inc. (Maple Grove, MN) from 2001 to 2026: 65 510(k) clearances. Most are in product codes NLH (Catheter, Recording, Electrode, Reprocessed) and NLQ (Single-Use Reprocessed Ultrasonic Surgical…). Since 2016 its 510(k)s took a median of 199 days from receipt to decision, against 155 for FDA’s reviews in the same codes and years. Its devices cite 111 predicates, 5 of them its own earlier devices. 24 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sterilmed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Sterilmed, 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 “Sterilmed”
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