510(k) Report

510(k) · Cleared

Cleared

Suction Guillotine Device

K932142510(k) TraditionalCleared Sep 24, 1993144-day reviewClass II21 CFR 876.1075

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

Triton Technology, Inc. · FCK Instrument, Biopsy, Suction

Cleared on Sep 24, 1993 after a 144-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 24, 1993
Review
144 days
Class
Class II
Product code
FCK
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K932142Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

How does its category compare?

All FCK devices

FCK Instrument, Biopsy, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCK

1in 2017

2011: 12017: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCK

Too few FCK 510(k)s in any year since 2007 to give a median.

Recalls per year · FCK

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FCK

1in 2025

2015: 22016: 12017: 12022: 32024: 72025: 1
2007high 7 (2024) · low 0 (2007)2025

MAUDE reports naming product code FCK, 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
20070—00
20080—00
20090—00
20100—00
20111—10
20120—00
20130—00
20140—00
20150—02
20160—01
20171—01
20180—00
20190—00
20200—00
20210—00
20220—03
20230—00
20240—07
20250—01
20260—0—

More from Triton Technology, Inc.

4 FDA decisions under this applicant name. See the company

  • K911448Multiple Biopsy Device-MBXTriton Technology, Inc. · 1991
  • K902883Tissue/Polyp Trap SystemTriton Technology, Inc. · 1990
  • K881303Triton Model 100 Pulsed Doppler Blood FlowmeterTriton Technology, Inc. · 1988

Recent decisions in FCK

The FCK category page

  • K153763Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc. · 2017
  • K103326Multiple Biopsy SystemUnited States Endoscopy Group, Inc. · 2011
  • K062159RB12 Suction Rectal Biopsy SystemAus Systems Pty, Ltd. · 2006
  • K061201Dsnare Diminutive Polypectomy and Suction System, Model 00711087United States Endoscopy Group, Inc. · 2006
  • K051637Dsnare, Model 00711087United States Endoscopy Group, Inc. · 2005

https://510kreport.com/device/K932142 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932142: Suction Guillotine Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932142

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026