510(k) · Cleared
ClearedReprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Aug 15, 2019 as substantially equivalent to K133314 (Ethicon Endo-Surgery, LLC, 2013) after a 157-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Aug 15, 2019
- Review
- 157 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K936109 (1994). 84 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations between
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 1 generation backK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- This deviceK190610 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc. · 2019
Show all 14 generations
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 13 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 12 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 11 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 10 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 9 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 8 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 6 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 5 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 4 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 1 generation backK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- This deviceK190610 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −13 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −11 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −10 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −9 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −8 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −6 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −5 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −4 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −3 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −2 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| −1 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| 0 (this device) | K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Sterilmed, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NLQ device
- #1 K233471 Reprocessed HARMONIC 1100 Shears, 5mm…score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133314 | Harmonic Focus Shears + Adaptive Tissue TechnologySummary page 6…ode NLQ HARMONIC FOCUS® Shears + Adaptive Tissue Technology Predicate Device: (Ethicon K133314) The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue Technolo… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 84 ancestors have a recall of any class.
- 4 other devices also cite its predicate K133314.
How does its category compare?
All NLQ devicesNLQ Single-Use Reprocessed Ultrasonic Surgical Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NLQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLQ
94in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLQ
44in 2025
MAUDE reports naming product code NLQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 1 | 25 |
| 2009 | 1 | — | 0 | 12 |
| 2010 | 2 | — | 0 | 33 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 1 | — | 0 | 113 |
| 2013 | 0 | — | 0 | 111 |
| 2014 | 3 | 303 | 0 | 63 |
| 2015 | 2 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 72 |
| 2017 | 3 | 94 | 0 | 87 |
| 2018 | 1 | — | 0 | 56 |
| 2019 | 2 | — | 0 | 45 |
| 2020 | 1 | — | 0 | 28 |
| 2021 | 1 | — | 0 | 40 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 0 | — | 1 | 16 |
| 2024 | 2 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190610: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190610
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026