510(k) Report

FDA applicant

Surgical Instrument Service and Savings, Inc.

Redmond, OR23 decisions2016–202518 recalls

FDA records 23 decisions for Surgical Instrument Service and Savings, Inc. (Redmond, OR) from 2016 to 2025: 23 510(k) clearances. Most are in product codes NLH (Catheter, Recording, Electrode, Reprocessed) and NUJ (Electrosurgical, Cutting & Coagulation…). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 0 of them its own earlier devices. 18 recalls are linked to its devices, 10 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Surgical Instrument Service and Savings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2025

2016: 32017: 52018: 22019: 22023: 12024: 52025: 5
2016high 5 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2026

2023: 12024: 12025: 15, 9 Class I2026 (partial year): 1, 1 Class I
2016high 15 (2025) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Surgical Instrument Service and Savings, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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