510(k) · Cleared
Recalled · Class II · 2021HARMONIC 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-Surgery, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Feb 28, 2020 as substantially equivalent to K160752 (Ethicon Endo-Suregery, LLC, 2016) after a 261-day review. Its family tree reaches back 4 generations to 2007. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 28, 2020
- Review
- 261 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K072177 (2007). 7 ancestors in all, the oldest K060245 (2006). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK072177 Enseal Vessel Sealing and Hemostasis SystemSurgrx, Inc. · 2007 · Recalled
- 3 generations backK112033 Enseal G2 Tissus SealersEthicon Endo-Sugery, LLC · 2011 · Recalled
- 2 generations backK132612 Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic…Ethicon Endo-Surgery, LLC · 2013 · Recalled
- 1 generation backK160752 HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36…Ethicon Endo-Suregery, LLC · 2016
- This deviceK191555 HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36…Ethicon Endo-Surgery, LLC · 2020
- Descendant · cites it directly · 4 of its ownK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length…Stryker Sustainability Solutions · 2024
- Descendant · 2 generations on · 0 of its ownK254196 HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK243067 The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) · 2025
- Descendant · 2 generations on · 0 of its ownK241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length…Stryker Sustainability Solutions · 2024
Most influential descendants
Showing 5 of 5 · See all- K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC · 2020 · cites it directly4descendants
- K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions · 2024 · 2 generations on1descendant
- K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026 · 2 generations on0descendants
- K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) · 2025 · 2 generations on0descendants
- K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K072177 | Enseal Vessel Sealing and Hemostasis System | Surgrx, Inc. | 2007 | 1 |
| −3 | K112033 | Enseal G2 Tissus Sealers | Ethicon Endo-Sugery, LLC | 2011 | 5 |
| −2 | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace +… | Ethicon Endo-Surgery, LLC | 2013 | 1 |
| −1 | K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length | Ethicon Endo-Suregery, LLC | 2016 | — |
| 0 (this device) | K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | Ethicon Endo-Surgery, LLC | 2020 | — |
| +1 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | 2020 | — |
| +2 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)… | Stryker Sustainability Solutions | 2024 | — |
| +2 | K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | 2026 | — |
| +2 | K243067 | The ETHICON™ Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025 | — |
| +2 | K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)… | Stryker Sustainability Solutions | 2024 | — |
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 | 1 | 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 |
|---|---|---|---|
| * | K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthSummary page 6…l Equivalence Comparison For purposes of the substantial equivalence comparisons, the following predicate device was selected: e HARMONIC HD 10001 Shears cleared under K160752 on June 29, 2016 The purpose of this 510(k) submission is notify the Agency of design changes since the baseline 510(k), K160752… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2021 | Class II | Z-2355-2021 | Process control | An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns |
| Jul 20, 2021 | Class II | Z-2356-2021 | Process control | An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K200841 (Ethicon Endo-Surgery, LLC, 2020) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191555: 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/K191555
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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