Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Sustainability Solutions — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
261 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Witho | Stryker Sustainability Solutions | 2026-06-18 | 112 | 0 |
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC | Stryker Sustainability Solutions | 2025-08-14 | 142 | 0 |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reproce | Stryker Sustainability Solutions | 2024-10-22 | 124 | 0 |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length | Stryker Sustainability Solutions | 2024-07-03 | 29 | 0 |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length | Stryker Sustainability Solutions | 2024-02-20 | 118 | 0 |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | 2023-07-25 | 53 | 0 |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | 2023-03-28 | 57 | 0 |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating | Stryker Sustainability Solutions | 2023-03-28 | 56 | 0 |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reproce | Stryker Sustainability Solutions | 2022-12-04 | 149 | 0 |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coatin | Stryker Sustainability Solutions | 2022-05-25 | 96 | 0 |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | 2022-05-13 | 88 | 0 |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse | Stryker Sustainability Solutions | 2022-03-08 | 326 | 0 |
| K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer) | Stryker Sustainability Solutions | 2022-03-08 | 326 | 0 |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advan | Stryker Sustainability Solutions | 2021-03-16 | 194 | 0 |
| K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSu | Stryker Sustainability Solutions | 2020-09-25 | 88 | 0 |
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | Stryker Sustainability Solutions | 2020-07-31 | 56 | 0 |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Ena | Stryker Sustainability Solutions | 2020-05-13 | 106 | 0 |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | 2019-05-08 | 261 | 1 |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | Stryker Sustainability Solutions | 2019-01-24 | 279 | 0 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions | 2018-04-23 | 56 | 0 |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, | Stryker Sustainability Solutions | 2018-04-20 | 59 | 0 |
| K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | Stryker Sustainability Solutions | 2017-11-16 | 57 | 0 |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technolo | Stryker Sustainability Solutions | 2017-04-05 | 49 | 1 |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanc | Stryker Sustainability Solutions | 2017-02-23 | 248 | 0 |
| K153415 | Reprocessed Stryker External Fixation Devices | Stryker Sustainability Solutions | 2016-01-13 | 49 | 0 |
| K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer | Stryker Sustainability Solutions | 2015-06-25 | 114 | 0 |
| K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECH | Stryker Sustainability Solutions | 2014-05-01 | 153 | 0 |
| K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | Stryker Sustainability Solutions | 2014-04-10 | 140 | 0 |
| K132629 | REPROCESSED DILATING TIP TROCARS | Stryker Sustainability Solutions | 2013-12-31 | 131 | 0 |
| K121855 | RESPROCESSED SERFAS ENERGY PROBE | Stryker Sustainability Solutions | 2012-08-16 | 52 | 0 |
| K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | 2011-10-21 | 72 | 1 |
| K112232 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Stryker Sustainability Solutions | 2011-09-26 | 53 | 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