510(k) · Cleared

Cleared

Integra Jarit Video Assisted Thoracic Surgery Instruments

K120012510(k) TraditionalCleared Sep 11, 2012252-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

Integra LifeSciences Corporation · GCJ Laparoscope, General & Plastic Surgery

Cleared on Sep 11, 2012 as substantially equivalent to K945474 (Scanlan Intl., Inc., 1994) and 3 other predicates after a 252-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Sep 11, 2012
Review: 252 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K925198 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925198 Kaiser NO Cannula Thoracoscopy/Laparoscopy InstrPilling Co. · 1993
This deviceK120012 Integra Jarit Video Assisted Thoracic Surgery InstrumentsIntegra LifeSciences Corporation · 2012
Descendant · cites it directly · 0 of its ownK152400 General & Plastic Surgery InstrumentsSontec Instruments, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all

K152400General & Plastic Surgery InstrumentsSontec Instruments, Inc. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925198	Kaiser NO Cannula Thoracoscopy/Laparoscopy Instr	Pilling Co.	1993	—
0 (this device)	K120012	Integra Jarit Video Assisted Thoracic Surgery Instruments	Integra LifeSciences Corporation	2012	—
+1	K152400	General & Plastic Surgery Instruments	Sontec Instruments, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K120012, 1993–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K945474	Scanlan (R) Thoracoscopic Scissors, Clamp, Forceps, Needle Holder Summary page 2 …3 n~w.Integralifecoom Predicate Devices: 510(k) # Device Product Code Manufacturer K945474 Scanlan@ Thoracoscopic GCJ Scanlan Intl, Inc. Scissors, Clamps, Forceps, Needle Hold…	Scanlan Intl., Inc.	1994	—
*	K925198	Kaiser NO Cannula Thoracoscopy/Laparoscopy Instr Summary page 2 …roduct Code Manufacturer K945474 Scanlan@ Thoracoscopic GCJ Scanlan Intl, Inc. Scissors, Clamps, Forceps, Needle Holder K925 198 Kaiser "No Cannula" Thoracoscopic/ GCJ Pilling Co. Laparoscopic Instruments K932456 Jarit Surgical In…	Pilling Co.	1993	—
*	K932456	Jarit Surgical Instruments Summary page 2 …Inc. Scissors, Clamps, Forceps, Needle Holder K925 198 Kaiser "No Cannula" Thoracoscopic/ GCJ Pilling Co. Laparoscopic Instruments K932456 Jarit Surgical Instruments KNF Integra York PA, Inc. K94 1565 Jarit Recommended Sinus EO…	J. Jamner Surgical Instruments, Inc.	1994	1
*	K941565	Jarit Recommended Sinus Instruments Summary page 2 …" Thoracoscopic/ GCJ Pilling Co. Laparoscopic Instruments K932456 Jarit Surgical Instruments KNF Integra York PA, Inc. K94 1565 Jarit Recommended Sinus EOB Integra York PA, Inc. Instruments Performance Standards: No perf…	J. Jamner Surgical Instruments, Inc.	1994	—

Also cleared against K945474: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152400	General & Plastic Surgery Instruments	Sontec Instruments, Inc.	2016	0

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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K152400 (Sontec Instruments, Inc., 2016) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K945474.

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. 2012, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

IntegraTM Jarit®P Video Assisted Thoracic Surgery (VATS) Instruments are manually operated instruments designed to perform specific functions such as cutting, grasping, clamping, dissecting, probing, draining, aspirating, suturing or ligating during open, mini-open, or thoracoscopic surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120012 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120012: Integra Jarit Video Assisted Thoracic Surgery Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120012

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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