510(k) · Cleared
ClearedMedline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Services and Savings (Dba Medline Renewal · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Jan 26, 2016 as substantially equivalent to K120729 (Ethicon Endo-Surgery, LLC, 2012) after a 245-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jan 26, 2016
- Review
- 245 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060245 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK060245 Harmonic Scalpel Blades and ShearsEthicon Endo-Surgery, Inc. · 2006
- 1 generation backK120729 Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive…Ethicon Endo-Surgery, LLC · 2012
- This deviceK151405 Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive…Surgical Instrument Services and Savings (Dba Medline Renewal · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060245 | Harmonic Scalpel Blades and Shears | Ethicon Endo-Surgery, Inc. | 2006 | — |
| −1 | K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue… | Ethicon Endo-Surgery, LLC | 2012 | — |
| 0 (this device) | K151405 | Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue… | Surgical Instrument Services and Savings (Dba Medline Renewal | 2016 | — |
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 |
|---|---|---|---|
| * | K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…Summary page 5…fied/scalpel, ultrasonic reprocessed Unclassified/scalpel ultrasonic, reprocessed Classification Product code: NLQ Predicate K120729 Ethicon Endo-Surgery Harmonic ACE® Shears+ Adaptive Tissue Device Technology Medline ReNewal Reproc… | 2012 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K120729.
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. 2016, 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?
Medline ReNewal 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/K151405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151405: Medline ReNewal 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 6, 2026. https://510kreport.com/device/K151405
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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