510(k) · Cleared
ClearedReprocessed Harmonic Ace Shears Without Adaptive Tissue Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on May 1, 2014 as substantially equivalent to K112072 (AtriCure, Inc., 2011) and 1 other predicate after a 153-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- May 1, 2014
- Review
- 153 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K942299 (1995). 48 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations between
- 3 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 2 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 1 generation backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- This deviceK133672 Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions · 2014
Show all 11 generations
- Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 10 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 9 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 8 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 7 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 6 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 5 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 4 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 3 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 2 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 1 generation backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- This deviceK133672 Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −10 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −9 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −8 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −7 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −6 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −5 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −4 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −3 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −2 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −1 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| 0 (this device) | K133672 | Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology | Stryker Sustainability Solutions | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K112072 | Atricure Cryo Module SystemSummary page 1…sification: Unclassified Product Code: NLQ Mdl Primary Predicate Secondary Predicate(s) Nubes K1120729 K060245 HAR36 HARMONICAACEO Shears + Harmonic Scalpel… | 2011 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 1…Product Code: NLQ Mdl Primary Predicate Secondary Predicate(s) Nubes K1120729 K060245 HAR36 HARMONICAACEO Shears + Harmonic Scalpel Blades and Shears, HAR23 Adaptive T… | 2006 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 48 ancestors have a recall of any class.
- 3 other devices also cite its predicate K112072.
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. 2014, 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?
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133672: Reprocessed Harmonic Ace Shears Without 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/K133672
Report an extraction error
Are you the manufacturer?
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