510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Jarit Surgical Instruments

K932456510(k) TraditionalCleared Apr 21, 1994335-day reviewClass II21 CFR 884.4160Recalls 1

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

J. Jamner Surgical Instruments, Inc. · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Cleared on Apr 21, 1994 after a 335-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Apr 21, 1994
Review
335 days
Class
Class II
Product code
KNF
Recalls
1
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2016: 1 descendant cleared1990200020102020
  1. This deviceK932456 Jarit Surgical InstrumentsJ. Jamner Surgical Instruments, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK120012 Integra Jarit Video Assisted Thoracic Surgery InstrumentsIntegra LifeSciences Corporation · 2012
  3. Descendant · 2 generations on · 0 of its ownK152400 General & Plastic Surgery InstrumentsSontec Instruments, Inc. · 2016
  4. Descendant · cites it directly · 0 of its ownK103726 Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation · 2012 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K120012Integra Jarit Video Assisted Thoracic Surgery InstrumentsIntegra LifeSciences Corporation · 2012 · cites it directly1descendant
  • K152400General & Plastic Surgery InstrumentsSontec Instruments, Inc. · 2016 · 2 generations on0descendants
  • K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932456Jarit Surgical InstrumentsJ. Jamner Surgical Instruments, Inc.1994—
+1K120012Integra Jarit Video Assisted Thoracic Surgery InstrumentsIntegra LifeSciences Corporation2012—
+2K152400General & Plastic Surgery InstrumentsSontec Instruments, Inc.2016—
+1K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201610
FIG. 1 — Lineage of K932456, 1994–2016Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KNF? 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 KNF device

  1. #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 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?

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

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120012Integra Jarit Video Assisted Thoracic Surgery InstrumentsIntegra LifeSciences Corporation20121
K103726Jarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 12, 2013Class IIZ-0886-2013OtherAddendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K120012 (Integra LifeSciences Corporation, 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KNF devices

KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNF

1in 2025

2007: 12010: 12012: 12013: 12014: 12018: 12020: 12021: 12022: 12023: 12024: 12025: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNF

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

Recalls per year · KNF

1in 2013

2009: 32013: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KNF

93in 2025

2008: 22009: 12010: 142011: 152012: 42013: 242014: 82015: 72016: 92017: 222018: 132019: 182020: 192021: 92022: 162023: 332024: 132025: 93
2007high 93 (2025) · low 0 (2007)2025

MAUDE reports naming product code KNF, 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
20071—00
20080—02
20090—31
20101—014
20110—015
20121—04
20131—124
20141—08
20150—07
20160—09
20170—022
20181—013
20190—018
20201—019
20211—09
20221—016
20231—033
20241—013
20251—093
20261—0—
Cite this page

510(k) Report. “K932456: Jarit Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932456

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