Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LFL — Predicate Candidate Screening
158 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
251 days90th percentile
158clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | 2026-07-30 | 90 | 0 |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2025-10-08 | 176 | 0 |
| K242894 | SanAgile™ Ultrasonic Surgery Advanced Portable Controller (S | Shanghai Saints Sages Surgical Co., Ltd. | 2025-06-18 | 268 | 0 |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments | 2025-03-24 | 94 | 0 |
| K241700 | Tenex 2nd Generation System | Trice Medical, Inc. | 2024-11-18 | 158 | 0 |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2024-07-11 | 142 | 0 |
| K233036 | Ultrasonic Surgical System | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2024-06-18 | 267 | 0 |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2023-07-11 | 144 | 0 |
| K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | 2023-06-23 | 64 | 0 |
| K221790 | HARMONIC 700 Shears | Ethicon Endo-Surgery, LLC | 2023-02-28 | 252 | 0 |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Stryker Corporation | 2023-02-16 | 63 | 0 |
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Sra Developments, Ltd. | 2022-12-15 | 245 | 0 |
| K210567 | Ultrasonic Surgical System | Miconvey Technologies Co., Ltd. | 2022-09-30 | 581 | 0 |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-08-22 | 60 | 0 |
| K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022-07-28 | 90 | 0 |
| K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022-07-18 | 334 | 0 |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-07-15 | 28 | 0 |
| K212049 | Oclet TDS 1000 | Tendonova Corporation | 2022-03-08 | 251 | 0 |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2022-02-03 | 57 | 0 |
| K212060 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2021-12-13 | 165 | 0 |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Devic | Covidien, LLC | 2021-11-15 | 115 | 0 |
| K212750 | Ultrasonic Surgical Aspirator System, Model: XD880B | Smtp Technology Co., Ltd. | 2021-09-27 | 28 | 0 |
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021-08-04 | 51 | 13 |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | Ethicon Endo-Surgery, LLC | 2021-05-21 | 24 | 0 |
| K202299 | Ultrasonic Surgical Aspirator System | Smtp Technology Co., Ltd. | 2021-05-21 | 281 | 0 |
| K200427 | Sonicision Cordless Ultrasonic Dissector | Covidien, LLC | 2020-07-10 | 140 | 0 |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020-06-23 | 90 | 0 |
| K192963 | Kogent Torus Ultrasonic Aspirator | Katalyst Surgical, LLC | 2020-06-19 | 240 | 0 |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Sh | Ethicon Endo-Surgery, LLC | 2020-02-28 | 261 | 0 |
| K190281 | Ultrasonic Surgical System | Medisonic Technology CO | 2019-10-31 | 262 | 0 |
| K190160 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2019-05-30 | 120 | 0 |
| K190070 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2019-04-11 | 86 | 0 |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2019-04-01 | 59 | 0 |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018-12-07 | 65 | 0 |
| K181367 | Tenex Health TX System with the TXP MicroTip | Tenex Health, Inc. | 2018-08-28 | 97 | 0 |
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery P | Covidien, LLC | 2018-03-26 | 66 | 0 |
| K172691 | Ultrasonic Generator | Olympus Medical Systems Corp. | 2017-10-04 | 28 | 0 |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2017-09-28 | 30 | 0 |
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016-10-14 | 95 | 1 |
| K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i She | Ethicon Endo-Suregery, LLC | 2016-06-29 | 103 | 0 |
| K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016-03-28 | 126 | 0 |
| K151136 | HARMONIC HOOK | Ethicon Endo-Surgery, LLC | 2016-03-04 | 310 | 0 |
| K153299 | Tenex Health TX System | Tenex Health, Inc. | 2016-03-03 | 111 | 0 |
| K150682 | CUSA Excel+ | Integra Lifesciences Corp. | 2015-12-18 | 276 | 0 |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015-07-17 | 84 | 0 |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2015-07-10 | 52 | 0 |
| K150271 | Prime Adaptive Ultrasonic Scalpel System | Endoprime, Inc. | 2015-05-29 | 114 | 0 |
| K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra LifeSciences Corporation | 2014-11-06 | 136 | 0 |
| K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra LifeSciences Corporation | 2014-11-06 | 136 | 1 |
| K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | Covidien, Formerly Valleylab, A Division of Tyco H | 2014-08-07 | 72 | 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