Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Surgical Instrument Service and Savings Inc.(Dba Medline Ren · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
240 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Cath | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024-11-15 | 197 | 2 |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2020-08-19 | 240 | 2 |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Div | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2018-10-31 | 41 | 5 |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic D | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017-07-03 | 94 | 0 |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divi | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-05-02 | 125 | 4 |
| K151617 | Livewire Electrophysiology Catheter | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-01-22 | 221 | 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