Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Surgical Instrument Service and Savings, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
378 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Intr | Surgical Instrument Service and Savings, Inc. | 2025-12-19 | 318 | 0 |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Un | Surgical Instrument Service and Savings, Inc. | 2025-11-26 | 118 | 0 |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Uni | Surgical Instrument Service and Savings, Inc. | 2025-07-11 | 120 | 0 |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco D | Surgical Instrument Service and Savings, Inc. | 2025-06-05 | 100 | 1 |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultras | Surgical Instrument Service and Savings, Inc. | 2025-03-10 | 161 | 0 |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnos | Surgical Instrument Service and Savings, Inc. | 2024-11-29 | 123 | 2 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electr | Surgical Instrument Service and Savings, Inc. | 2024-09-14 | 141 | 3 |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultraso | Surgical Instrument Service and Savings, Inc. | 2024-09-10 | 263 | 2 |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Conne | Surgical Instrument Service and Savings, Inc. | 2024-06-07 | 59 | 0 |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-c | Surgical Instrument Service and Savings, Inc. | 2024-04-29 | 255 | 1 |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steera | Surgical Instrument Service and Savings, Inc. | 2023-05-31 | 414 | 3 |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Ped | Surgical Instrument Service and Savings, Inc. | 2019-07-03 | 77 | 0 |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Sut | Surgical Instrument Service and Savings, Inc. | 2019-04-15 | 192 | 0 |
| K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fi | Surgical Instrument Service and Savings, Inc. | 2018-07-27 | 144 | 0 |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic D | Surgical Instrument Service and Savings, Inc. | 2018-07-12 | 230 | 0 |
| K171911 | Medline ReNewal Reprocessed Synthes External Fixation System | Surgical Instrument Service and Savings, Inc. | 2017-11-09 | 136 | 0 |
| K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | Surgical Instrument Service and Savings, Inc. | 2017-10-18 | 48 | 0 |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017-08-03 | 444 | 0 |
| K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith | Surgical Instrument Service and Savings, Inc. | 2017-06-23 | 49 | 0 |
| K161272 | Supreme and Response Electrophysiology Catheters | Surgical Instrument Service and Savings, Inc. | 2017-05-18 | 378 | 0 |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Device | Surgical Instrument Service and Savings, Inc. | 2016-12-28 | 58 | 0 |
| K160333 | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/D | Surgical Instrument Service and Savings, Inc. | 2016-07-20 | 163 | 6 |
| K160740 | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVI | Surgical Instrument Service and Savings, Inc. | 2016-05-06 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda