510(k) Report

510(k) · Cleared

Cleared

Prime Adaptive Ultrasonic Scalpel System

K150271510(k) TraditionalCleared May 29, 2015114-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endoprime, Inc. · LFL Instrument, Ultrasonic Surgical

Cleared on May 29, 2015 as substantially equivalent to K002981 (Ethicon Endo-Surgery, Inc., 2001) and 3 other predicates after a 114-day review. Its family tree reaches back 2 generations to 1995.

Decided
May 29, 2015
Review
114 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K952726 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2001: 2 other ancestorsReference device: K010309 · Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator · Mutoh America Co., Ltd. · 2001 · recalledK952726 · Ultracision Harmonic Scapel · Ultracision, Inc. · 1995K990430 · Ultracision Harmonic Scalpel Hand Piece · Ethicon Endo-Surgery, Inc. · 199919952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors K990430 · Ultracision Harmonic Scalpel Hand Piece · Ethicon Endo-Surgery, Inc. · 1999K952726 · Ultracision Harmonic Scapel · Ultracision, Inc. · 19950
  1. Root · 2 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
  2. 1 generation backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
  3. This deviceK150271 Prime Adaptive Ultrasonic Scalpel SystemEndoprime, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K952726Ultracision Harmonic ScapelUltracision, Inc.1995—
−1K990430Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc.1999—
0 (this device)K150271Prime Adaptive Ultrasonic Scalpel SystemEndoprime, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200610
FIG. 1 — Lineage of K150271, 1995–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K002981Ultracision Harmonic Scalpel Coagulating Shears, Model…
Summary page 7
…cturer’s systems. Prime™ Adaptive Ultrasonic Scalpel System products are compatible with a limited number of other predicate systems. Predicate Device(s): K002981-Ultracision Harmonic Scalpel, Ethicon Endo-Surgery, Inc. K990430-Ultracision HARMONIC Scalpel Hand Piece, Ethicon Endo…
Ethicon Endo-Surgery, Inc.2001—
*K990430Ultracision Harmonic Scalpel Hand Piece
Summary page 7
…compatible with a limited number of other predicate systems. Predicate Device(s): K002981-Ultracision Harmonic Scalpel, Ethicon Endo-Surgery, Inc. K990430-Ultracision HARMONIC Scalpel Hand Piece, Ethicon Endo-Surgery K010898-Ultracision Harmonic Scalpel Blade, Ethicon Endo-S…
Ethicon Endo-Surgery, Inc.1999—
*K010898Ultracision Harmonic Scalpel Blades, Model DH105,DH145,SH105, SH145,HC145
Summary page 7
…evice(s): K002981-Ultracision Harmonic Scalpel, Ethicon Endo-Surgery, Inc. K990430-Ultracision HARMONIC Scalpel Hand Piece, Ethicon Endo-Surgery K010898-Ultracision Harmonic Scalpel Blade, Ethicon Endo-Surgery K053056-Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery,…
Ethicon Endo-Surgery, Inc.2001—
*K053056Harmonic Scalpel Blades and Shears
Summary page 7
…rgery, Inc. K990430-Ultracision HARMONIC Scalpel Hand Piece, Ethicon Endo-Surgery K010898-Ultracision Harmonic Scalpel Blade, Ethicon Endo-Surgery K053056-Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. Prime™ Adaptive Ultrasonic Scalpel System blade tips are finished…
Ethicon Endo-Surgery, Inc.2006—
†K010309Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorMutoh America Co., Ltd.20014

Also cleared against K002981: 2 other devices →

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 20 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
  • None of the 5 ancestors has a recall.
  • 2 other devices also cite its predicate K002981.

How does its category compare?

All LFL devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LFL

3in 2025

2007: 72008: 22009: 12010: 22011: 32012: 32013: 52014: 32015: 42016: 52017: 22018: 32019: 42020: 42021: 62022: 82023: 42024: 32025: 32026 (partial year): 3
2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007: 99 days median2011: 241 days median2012: 82 days median2013: 73 days median2014: 136 days median2015: 99 days median2016: 111 days median2018: 66 days median2019: 103 days median2020: 190 days median2021: 83 days median2022: 168 days median2023: 104 days median2024: 158 days median2025: 176 days median2026 (partial year): 99 days median
2007high 241 (2011) · low 66 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFL

11in 2024

2010: 32011: 22012: 52014: 12015: 12017: 12019: 422021: 12023: 22024: 112026 (partial year): 1
2007high 42 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFL

3,857in 2025

2007: 2,2362008: 1,6782009: 3,3242010: 1,2392011: 1,0532012: 1,4912013: 2,4302014: 4,2602015: 2,7772016: 2,6912017: 3,2672018: 3,4612019: 3,1532020: 2,9342021: 3,2892022: 3,4222023: 4,2152024: 4,0172025: 3,857
2007high 4,260 (2014) · low 1,053 (2011)2025

MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200779902,236
20082—01,678
20091—03,324
20102—31,239
2011324121,053
201238251,491
201357302,430
2014313614,260
201549912,777
2016511102,691
20172—13,267
201836603,461
20194103423,153
2020419002,934
202168313,289
2022816803,422
2023410424,215
20243158114,017
2025317603,857
20263991—

What is it indicated for?

The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic, and endoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K002981

2 other devices cite the same predicate.

  • K031523Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
  • K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003

Recent decisions in LFL

The LFL category page

  • K261361TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque…Carl Zeiss Meditec, AG · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
  • K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2025
  • K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced…Shanghai Saints Sages Surgical Co., Ltd. · 2025

https://510kreport.com/device/K150271 · printed Nov 3, 2026

Cite this page

510(k) Report. “K150271: Prime Adaptive Ultrasonic Scalpel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150271

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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