510(k) · Cleared

Cleared

Aim 200, Major Surgical Light

K101537510(k) TraditionalCleared Sep 30, 2010119-day reviewClass II21 CFR 878.4580

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

Burton Medical Products Corp. · FSY Light, Surgical, Ceiling Mounted

Cleared on Sep 30, 2010 as substantially equivalent to K042395 (Burton Medical Products Corp., 2004) after a 119-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Sep 30, 2010
Review: 119 days
Class: Class II
Product code: FSY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042395 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK042395 Outpatient Iii Minor Surgery LightBurton Medical Products Corp. · 2004
This deviceK101537 Aim 200, Major Surgical LightBurton Medical Products Corp. · 2010
Descendant · cites it directly · 0 of its ownK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013

Most influential descendants

Showing 1 of 1 · See all

K132747Visum Blade Led Surgical Lighting SystemStryker Communications · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042395	Outpatient Iii Minor Surgery Light	Burton Medical Products Corp.	2004	—
0 (this device)	K101537	Aim 200, Major Surgical Light	Burton Medical Products Corp.	2010	—
+1	K132747	Visum Blade Led Surgical Lighting System	Stryker Communications	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K101537, 2004–2013Source: 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 FSY? 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? (1)

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
*	K042395	Outpatient Iii Minor Surgery Light Summary page 1 …device was changed to "AIMI100 Minor Surgery Light" subsequent to clearance by the FDA.) Predicate "K" number: K042395 Predicate submitter: Burton Medical Products Inc. Predicate clearance date: 0I-Dec-2004 Product descripti…	Burton Medical Products Corp.	2004	—

Also cleared against K042395: 1 other device →

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
K132747	Visum Blade Led Surgical Lighting System	Stryker Communications	2013	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?

Its one ancestor has no recall.
Of its descendants, K132747 (Stryker Communications, 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K042395.

How does its category compare?

All FSY devices

FSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FSY

7in 2014

2007high 7 (2014) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FSY

59in 2014

2007high 130 (2010) · low 29 (2007)2026

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

Recalls per year · FSY

11in 2023

2007high 228 (2015) · low 0 (2007)2026

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

Adverse event reports per year · FSY

286in 2025

2007high 663 (2023) · low 40 (2009)2025

MAUDE reports naming product code FSY, 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	29	0	70
2008	2	—	0	53
2009	2	—	4	40
2010	5	130	3	72
2011	0	—	4	70
2012	2	—	4	171
2013	3	118	1	137
2014	7	59	0	139
2015	0	—	228	175
2016	0	—	0	182
2017	0	—	0	162
2018	0	—	2	316
2019	0	—	4	444
2020	0	—	0	439
2021	0	—	0	380
2022	0	—	0	430
2023	0	—	11	663
2024	0	—	0	541
2025	0	—	0	286
2026	0	—	4	—

What is it indicated for?

The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 200® OR Major Surgical Light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101537 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101537: Aim 200, Major Surgical Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101537

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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