510(k) · Cleared
ClearedHARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Suregery, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Jun 29, 2016 as substantially equivalent to K132612 (Ethicon Endo-Surgery, LLC, 2013) after a 103-day review. Its family tree reaches back 3 generations to 2007. 6 later devices descend from it.
- Decided
- Jun 29, 2016
- Review
- 103 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K072177 (2007). 6 ancestors in all, the oldest K060245 (2006). 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK072177 Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 2007 · Recalled
- 2 generations backK112033 Enseal G2 Tissus SealersEthicon Endo-Sugery, LLC · 2011 · Recalled
- 1 generation backK132612 Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic…Ethicon Endo-Surgery, LLC · 2013 · Recalled
- This deviceK160752 HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36…Ethicon Endo-Suregery, LLC · 2016
- Descendant · cites it directly · 5 of its ownK191555 HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36…Ethicon Endo-Surgery, LLC · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- Descendant · 3 generations on · 1 of its ownK233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length…Stryker Sustainability Solutions · 2024
- Descendant · 3 generations on · 0 of its ownK254196 HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK243067 The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC · 2020 · cites it directly5descendants
- K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC · 2020 · 2 generations on4descendants
- K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions · 2024 · 3 generations on1descendant
- K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026 · 3 generations on0descendants
- K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072177 | Enseal Vessel Sealing and Hemostasis System | Surgrx, Inc. | 2007 | 1 |
| −2 | K112033 | Enseal G2 Tissus Sealers | Ethicon Endo-Sugery, LLC | 2011 | 5 |
| −1 | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace +… | Ethicon Endo-Surgery, LLC | 2013 | 1 |
| 0 (this device) | K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length | Ethicon Endo-Suregery, LLC | 2016 | — |
| +1 | K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | Ethicon Endo-Surgery, LLC | 2020 | 2 |
| +2 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | 2020 | — |
| +3 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)… | Stryker Sustainability Solutions | 2024 | — |
| +3 | K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | 2026 | — |
| +3 | K243067 | The ETHICON™ Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 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 |
|---|---|---|---|
| * | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Summary page 4…ent, Ultrasonic Surgical (Unassigned, Product Code: LFL) Regulatory Class Unclassified Predicate Device HARMONIC ACE®+ Shears with Advanced Hemostasis, cleared under K132612 on October 17th, 2013 Device Description The HARMONIC HD 1000i Shears are a sterile, single patient use device used for dissecti… | 2013 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | 2020 | 5 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K191555 (Ethicon Endo-Surgery, LLC, 2020) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K132612.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The Harmonic HD 1000i Shears instrument is 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, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160752: HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160752
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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