510(k) · Cleared

Recalled · Class II · 2023

Alm Prismalix (PRX) Surgical Light

K982063510(k) TraditionalCleared Sep 22, 1998102-day reviewClass II21 CFR 878.4580Recalls 1

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

Alm Surgical Equipment, Inc. · FSY Light, Surgical, Ceiling Mounted

Cleared on Sep 22, 1998 as substantially equivalent to K882613 (Alm Surgical Equipment, Inc., 1988) and 3 other predicates after a 102-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it. It has been recalled once.

Decided: Sep 22, 1998
Review: 102 days
Class: Class II
Product code: FSY
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K860739 (1986). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK860739 Chick Surigical LightProfessional Medical Products, Inc. · 1986
This deviceK982063 Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 1998
Descendant · cites it directly · 0 of its ownK040015 Modification to Prismalix Surgical LightAlm S.A. · 2004
Descendant · cites it directly · 0 of its ownK030906 Axcel Surgical LightAlm · 2003 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K040015Modification to Prismalix Surgical LightAlm S.A. · 2004 · cites it directly0descendants
K030906Axcel Surgical LightAlm · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860739	Chick Surigical Light	Professional Medical Products, Inc.	1986	—
0 (this device)	K982063	Alm Prismalix (PRX) Surgical Light	Alm Surgical Equipment, Inc.	1998	—
+1	K040015	Modification to Prismalix Surgical Light	Alm S.A.	2004	—
+1	K030906	Axcel Surgical Light	Alm	2003	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1992	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K982063, 1986–2004Source: 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? (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
*	K882613	Alm Surgical Lamps Summary page 1 …inues to be manufactured by the parent organization, ALM SA. The new product known as “Prismalix™” is of similar technology to surgical lights covered under D.C. Number K882613 issued on June 29, 1988. The differences between the new Prismalix™ models and models previously sold are cosmetic along with the…	Alm Surgical Equipment, Inc.	1988	2
*	K922836	Chromophare Summary page 2 …820 North Lemon Street, Anaheim, CA 92801 Reviewed by the FDA (K882613), 06/29/88 2. Berchtold Corporation, 1950 Hanahan Road, Charleston, SC 29419 Reviewed by the FDA (K922836), 10/09/92 3. Steris (Amsco)Corporation, 5960 Heisley Road, Mentor, OH 44060, Reviewed by the FDA (K943288), 10/17/94 SS & E Pa…	Berchtold Holding GmbH	1992	1
*	K943288	Amsco SQ240 Surgical Light Summary page 2 …1950 Hanahan Road, Charleston, SC 29419 Reviewed by the FDA (K922836), 10/09/92 3. Steris (Amsco)Corporation, 5960 Heisley Road, Mentor, OH 44060, Reviewed by the FDA (K943288), 10/17/94 SS & E Page 2 4. Midmark (Chick Surgical), Versalilles, OH 45380 Reviewed by the FDA (K860739), 03/28…	American Sterilizer Co.	1994	—
*	K860739	Chick Surigical Light Summary page 3 …ey Road, Mentor, OH 44060, Reviewed by the FDA (K943288), 10/17/94 SS & E Page 2 4. Midmark (Chick Surgical), Versalilles, OH 45380 Reviewed by the FDA (K860739), 03/28/86 All of these systems are ceiling, wall or mobile mounted surgical lights intended to provide acceptable levels of ill…	Professional Medical Products, Inc.	1986	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K040015	Modification to Prismalix Surgical Light	Alm S.A.	2004	0
K030906	Axcel Surgical Light	Alm	2003	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 8, 2023	Class II	Z-0767-2024	Equipment maintenance	A potential for a light system to fall in the operating room.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K040015 (Alm S.A., 2004) has gone furthest, with 0 descendants of its own.

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.

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?

ALM Prismalix (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadows, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. Use is by surgeons and other medical care givers. The ALM PRX Surgical Lights will be used in indications which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

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/K982063 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982063: Alm Prismalix (PRX) Surgical Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982063

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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