510(k) Report

510(k) · Cleared

Cleared

Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion Diamond Cannulas

K972958510(k) TraditionalCleared Sep 19, 199739-day reviewClass II21 CFR 876.1500

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

Lysonix, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Sep 19, 1997 as substantially equivalent to K962525 (Morwel Corp., 1996) and 5 other predicates after a 39-day review. Its family tree reaches back 1 generation to 1983.

Decided
Sep 19, 1997
Review
39 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K832520 (1983). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1986: 2 other ancestorsK832520 · Suction Tips · Wells Johnson Co. · 19831980198519901995
Other ancestors, by generation 1 generation back: 5 other ancestors K832520 · Suction Tips · Wells Johnson Co. · 19830
  1. Root · 1 generation backK832520 Suction TipsWells Johnson Co. · 1983
  2. This deviceK972958 Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix…Lysonix, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K832520Suction TipsWells Johnson Co.1983—
0 (this device)K972958Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion…Lysonix, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
199110
199410
199610
FIG. 1 — Lineage of K972958, 1983–1997Source: 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 GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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
*K962525Ultra-Safe Ultrasonic Aspirator System
Summary page 1
…ommercial distribution by the following companies: 1. Ultra-Safe Ultrasonic Aspirator System (including suction cannulas); Morwel Corporation, Tucson, AZ; 510(k) number K962525 2. Suction Tips; Wells Johnson Company, Tucson, AZ; 510(k) number K832520 3. Endo-Pool Suction Cannulas and Irrigation Probes;…
Morwel Corp.1996—
*K832520Suction Tips
Summary page 1
…c Aspirator System (including suction cannulas); Morwel Corporation, Tucson, AZ; 510(k) number K962525 2. Suction Tips; Wells Johnson Company, Tucson, AZ; 510(k) number K832520 3. Endo-Pool Suction Cannulas and Irrigation Probes; Davol, Inc., Cranston, RI; 510(k) numbers K914526 and 926479 4. Newman Can…
Wells Johnson Co.1983—
*K914526Davol Endo-Flo Suct/Irri Probe (for Gen Surgery)
Summary page 1
…2. Suction Tips; Wells Johnson Company, Tucson, AZ; 510(k) number K832520 3. Endo-Pool Suction Cannulas and Irrigation Probes; Davol, Inc., Cranston, RI; 510(k) numbers K914526 and 926479 4. Newman Cannulae System; Byron Medical Corporation, Tucson, AZ; 510(k) number K862936 5. Byron Suction Tips; Byron…
Davol, Inc.1991—
*K926479Bard Laparoscopic Irrigator Pump System
Summary page 1
…ips; Wells Johnson Company, Tucson, AZ; 510(k) number K832520 3. Endo-Pool Suction Cannulas and Irrigation Probes; Davol, Inc., Cranston, RI; 510(k) numbers K914526 and 926479 4. Newman Cannulae System; Byron Medical Corporation, Tucson, AZ; 510(k) number K862936 5. Byron Suction Tips; Byron Medical Co…
Davol, Inc.1994—
*K862936Newman Cannulae System (NCS)
Summary page 1
…ulas and Irrigation Probes; Davol, Inc., Cranston, RI; 510(k) numbers K914526 and 926479 4. Newman Cannulae System; Byron Medical Corporation, Tucson, AZ; 510(k) number K862936 5. Byron Suction Tips; Byron Medical Corporation, Tucson, AZ 510(k) number K861878 IV. DESCRIPTION The LySonix Suction/Aspirat…
Byron Medical1986—
*K861878Byron Suction Tips
Summary page 1
…6479 4. Newman Cannulae System; Byron Medical Corporation, Tucson, AZ; 510(k) number K862936 5. Byron Suction Tips; Byron Medical Corporation, Tucson, AZ 510(k) number K861878 IV. DESCRIPTION The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or…
Byron Medical1986—

Also cleared against K962525: 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?

  • None of the 6 ancestors has a recall.
  • 2 other devices also cite its predicate K962525.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The LySonix Cannulas are instruments used for suction or aspiration of fluids and tissue and for

infusion of fluids during a variety of surgical procedures.

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 K962525

2 other devices cite the same predicate.

  • K980895Allegro Ultrasonic Soft Tissue AspiratorCalifornia Institute of Tissue Eng. & Instrumenti · 1998
  • K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997

More from Lysonix, Inc.

5 FDA decisions under this applicant name. See the company

  • K980771Lysonix Suction Lipoplasty SystemLysonix, Inc. · 1998
  • K980763Lysonix Lipoplasty Access PortLysonix, Inc. · 1998
  • K980454Lysonix Aspiration PumpLysonix, Inc. · 1998
  • K974233Lysonix Irrigation SystemLysonix, Inc. · 1998

Recent decisions in GCJ

The GCJ category page

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https://510kreport.com/device/K972958 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972958: Lysonix TTD Delta Scavenger Suction/Aspiration Cannulas Lysonix Infusion Diamond Cannulas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972958

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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