Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NLQ — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
303 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC | Stryker Sustainability Solutions | 2025-08-14 | 142 | 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 |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advan | Stryker Sustainability Solutions | 2021-03-16 | 194 | 0 |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2020-08-19 | 240 | 2 |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technolo | Sterilmed, Inc. | 2019-08-15 | 157 | 0 |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Sterilmed, Inc. | 2019-04-15 | 236 | 0 |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic D | Surgical Instrument Service and Savings, Inc. | 2018-07-12 | 230 | 0 |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic D | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017-07-03 | 94 | 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 |
| K151405 | Medline ReNewal Reprocessed Harmonic ACE + Shears without Ad | Surgical Instrument Services and Savings(Dba Medline Renewal | 2016-01-26 | 245 | 0 |
| K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without A | Surgical Instrument Services and Savings, Inc. | 2015-12-16 | 289 | 0 |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | Sterilmed, Inc. | 2015-05-20 | 155 | 0 |
| K132566 | REPROCESSED HARMONIC SHEAR | Sterilmed, Inc. | 2014-06-14 | 303 | 0 |
| K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECH | Stryker Sustainability Solutions | 2014-05-01 | 153 | 0 |
| K124033 | MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS | Surgical Instruments Service and Savings, Inc. | 2014-01-07 | 375 | 0 |
| K111794 | REPROCESSED HARMONIC SCALPEL | Sterilmed, Inc. | 2012-01-11 | 198 | 0 |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND | Ascent Healthcare Solutions | 2010-05-12 | 76 | 0 |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | Ascent Healthcare Solutions | 2010-03-04 | 93 | 0 |
| K083060 | REPROCESSED HARMONIC SCALPEL | Sterilmed, Inc. | 2009-01-09 | 87 | 0 |
| K043358 | REPROCESSED ULTRASONIC SCALPELS | Alliance Medical Corp. | 2005-06-06 | 182 | 0 |
| K050343 | REPROCESSED HARMONIC SCALPELS | Sterilmed, Inc. | 2005-04-12 | 60 | 2 |
| K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | Vanguard Medical Concepts, Inc. | 2005-03-22 | 111 | 0 |
| K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | Vanguard Medical Concepts, Inc. | 2005-03-22 | 120 | 0 |
| K030598 | MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS | Medisiss | 2004-01-23 | 332 | 0 |
| K012571 | REPROCESSED HARMONIC | Sterilmed, Inc. | 2001-11-07 | 90 | 1 |
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