510(k) · Cleared

Recalled · Class II · 2015

Trulight 5520 and Trulight 5320

K102758510(k) TraditionalCleared Oct 26, 201033-day reviewClass II21 CFR 878.4580Recalls 2

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

Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · FSY Light, Surgical, Ceiling Mounted

Cleared on Oct 26, 2010 as substantially equivalent to K061317 (Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, 2006) and 1 other predicate after a 33-day review. Its family tree reaches back 3 generations to 1997. It has been recalled 2 times.

Decided: Oct 26, 2010
Review: 33 days
Class: Class II
Product code: FSY
Recalls: 2
Predicates: 3

Its longest line of descent runs back 3 generations to K965130 (1997). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
2 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
1 generation backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
This deviceK102758 Trulight 5520 and Trulight 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K965130	Chromophare	Berchtold Holding GmbH	1997	—
−2	K024132	Chromophare X 65	Berchtold Holding GmbH	2003	—
−1	K061317	ILED	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg	2006	7
0 (this device)	K102758	Trulight 5520 and Trulight 5320	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0

FIG. 1 — Lineage of K102758, 1997–2010Source: 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K061317	ILED Summary page 1 …Code: FSY Device Relationships TRUMPF Medical Systems, Inc. distributes "Surgical light, Ceiling Mounted, ILED" systems cleared under K061317 with one to three arms per suspension. The devices are offered in a variety of comb…	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg	2006	7
Kept off the family tree	K019246	Surgical Lamp, Mobile Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K011693	Trumpf Surgical Lights, Models 301,501,701,1001 Summary page 2 …1-6 TRUMPF Medical Systems, Inc. listed a surgical light Helion 501 and 701 cleared under K01 1693. This light was available with a laser focus feature. The laser was a Class 2 laser and…	Trumpf Medical Systems, Inc.	2001	3

Also cleared against K061317: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 2, 2015	Class II	Z-0563-2016	Other	The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
Jan 9, 2012	Not classified	Z-1010-2012	Device Design	The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
2 of the 5 ancestors have a recall of any class.
6 other devices also cite its predicate K061317.

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 TRUMPF Surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102758: Trulight 5520 and Trulight 5320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102758

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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