510(k) · Cleared

Cleared

Optical Separator

K032889510(k) TraditionalCleared Oct 2, 200315-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

Applied Medical Resources · GCJ Laparoscope, General & Plastic Surgery

Cleared on Oct 2, 2003 as substantially equivalent to K990028 (Ethicon Endo-Surgery, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1999. 13 later devices descend from it.

Decided: Oct 2, 2003
Review: 15 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K990028 (1999). 2 ancestors in all. 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
This deviceK032889 Optical SeparatorApplied Medical Resources · 2003
Descendant · cites it directly · 10 of its ownK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006 · Recalled
Descendant · 2 generations on · 4 of its ownK083638 Fixation TrocarsApplied Medical Resources Corp. · 2008 · Recalled
Descendant · 3 generations on · 2 of its ownK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021
Descendant · 2 generations on · 2 of its ownK072674 Kii Trocar SystemApplied Medical Resources Corp. · 2007 · Recalled
Descendant · cites it directly · 2 of its ownK041795 Modification to Optical Separator SystemApplied Medical Resources Corp. · 2004 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2004high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 13 · See all

K060096Modular Trocar SystemApplied Medical Resources Corp. · 2006 · cites it directly10descendants
K083638Fixation TrocarsApplied Medical Resources Corp. · 2008 · 2 generations on4descendants
K211577SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021 · 3 generations on2descendants
K072674Kii Trocar SystemApplied Medical Resources Corp. · 2007 · 2 generations on2descendants
K041795Modification to Optical Separator SystemApplied Medical Resources Corp. · 2004 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990028	Endopath Optiview Optical Surgical Obturator and Sleeve	Ethicon Endo-Surgery, Inc.	1999	—
0 (this device)	K032889	Optical Separator	Applied Medical Resources	2003	—
+1	K060096	Modular Trocar System	Applied Medical Resources Corp.	2006	7
+2	K083638	Fixation Trocars	Applied Medical Resources Corp.	2008	1
+3	K211577	SoftFix Balloon Trocar	Unimax Medical Systems, Inc.	2021	—
+2	K072674	Kii Trocar System	Applied Medical Resources Corp.	2007	2
+1	K041795	Modification to Optical Separator System	Applied Medical Resources Corp.	2004	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	2	0
2008	1	0
2011	1	0
2017	1	0
2020	1	0
2021	2	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K032889, 1999–2026Source: 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? (2)

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
*	K990028	Endopath Optiview Optical Surgical Obturator and Sleeve Summary page 1 …EndoPath Optiview Optical Surgical Obturator, Ethicon-Endo-Surgery, Inc. Cincinnati, OH. (K990028) Applied Medical Dilating Tip Obturator Applied Medical,…	Ethicon Endo-Surgery, Inc.	1999	—
*	K012884	Dilating Tip Obturator Summary page 1 …Applied Medical Dilating Tip Obturator Applied Medical, Rancho Santa Margarita, CA (K012884) INTENDED USE: The Optical Separator is a sterile single use device, intended fa ise in conjunction with Applied’s currently mar…	Applied Medical Resources Corp.	2002	7

Also cleared against K990028: 2 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K060096	Modular Trocar System	Applied Medical Resources Corp.	2006	10
K041795	Modification to Optical Separator System	Applied Medical Resources Corp.	2004	2
K111002	Reprocessed Endoscopic Trocars	Sterilmed, Inc.	2011	0
K063788	Reprocessed Endoscopic Trocars and Cannulas	Ascent Healthcare Solutions	2007	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 2 ancestors has a recall of any class.
Of its descendants, K060096 (Applied Medical Resources Corp., 2006) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K990028.

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

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?

The Optical Separator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032889 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032889: Optical Separator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032889

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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