510(k) · Cleared

Cleared

Smith & Nephew Subcutaneous Illuminator

K991323510(k) TraditionalCleared Jul 6, 199978-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

Smith & Nephew, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope

Cleared on Jul 6, 1999 as substantially equivalent to K963646 (Stryker Endoscopy, 1997) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.

Decided: Jul 6, 1999
Review: 78 days
Class: Class II
Product code: FFS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K964561 (1997). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK964561 Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and…Bioenterics Corp. · 1997
This deviceK991323 Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999
Descendant · cites it directly · 1 of its ownK032387 Trivex SystemSmith & Nephew, Inc. · 2003 · Recalled
Descendant · 2 generations on · 0 of its ownK212894 PhasTIPPLeMaitre Vascular, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all

K032387Trivex SystemSmith & Nephew, Inc. · 2003 · cites it directly1descendant
K212894PhasTIPPLeMaitre Vascular, Inc. · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964561	Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR…	Bioenterics Corp.	1997	—
0 (this device)	K991323	Smith & Nephew Subcutaneous Illuminator	Smith & Nephew, Inc.	1999	—
+1	K032387	Trivex System	Smith & Nephew, Inc.	2003	1
+2	K212894	PhasTIPP	LeMaitre Vascular, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2022	1	0

FIG. 1 — Lineage of K991323, 1997–2022Source: 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 FFS? 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

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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
*	K963646	Stryker Strykeflow Suction Irrigator Gravity Flow Summary page 1 …cs Endoscope for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities, the Strykeflow Suction Irrigator Gravity Flow marketed by Stryker Endoscopy(K963646), the Endolumina Transillumination System II marketed by BioEnterics (K964561) and the AMD Fiberoptic End Irrigating Endo-Illumin…	Stryker Endoscopy	1997	2
*	K964561	Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020… Summary page 1 …er Extremities, the Strykeflow Suction Irrigator Gravity Flow marketed by Stryker Endoscopy(K963646), the Endolumina Transillumination System II marketed by BioEnterics (K964561) and the AMD Fiberoptic End Irrigating Endo-Illuminator (K970882). Predicate Devices: The predicate devices for this submission…	Bioenterics Corp.	1997	—
*	K970882	Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.) Summary page 1 …keted by Stryker Endoscopy(K963646), the Endolumina Transillumination System II marketed by BioEnterics (K964561) and the AMD Fiberoptic End Irrigating Endo-Illuminator (K970882). Predicate Devices: The predicate devices for this submission are the Dyonics Endoscope for Endoscopic Surgery of Superficial…	American Medical Devices, Inc.	1997	—
*	—	Dyonics Endoscope for Endoscopic Surgery of Superficial Veins and Fascia of the Lower… Named without a submission number			—

Also cleared against K963646: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K032387	Trivex System	Smith & Nephew, Inc.	2003	1

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 3 ancestors has a recall of any class.
Of its descendants, K032387 (Smith & Nephew, Inc., 2003) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K963646.

How does its category compare?

All FFS devices

FFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFS

3in 2007

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFS

74in 2007

2007high 74 (2007)2026

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

Recalls per year · FFS

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FFS

5in 2024

2007high 57 (2021) · low 0 (2025)2025

MAUDE reports naming product code FFS, 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	3	74	1	12
2008	0	—	0	17
2009	0	—	0	14
2010	0	—	0	5
2011	0	—	0	7
2012	0	—	0	4
2013	0	—	0	10
2014	0	—	0	5
2015	0	—	0	4
2016	0	—	0	7
2017	0	—	0	19
2018	0	—	0	19
2019	0	—	0	17
2020	0	—	0	56
2021	0	—	0	57
2022	0	—	0	10
2023	0	—	0	6
2024	0	—	0	5
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Subcutaneous Illuminator is intended to be used for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991323: Smith & Nephew Subcutaneous Illuminator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991323

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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