510(k) Report

510(k) · Cleared

Recalled · 2009

Alm Surgical Lamps

K882613510(k) TraditionalCleared Jul 18, 198824-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

Alm Surgical Equipment, Inc. · FTD Lamp, Surgical

Cleared on Jul 18, 1988 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.

Decided
Jul 18, 1988
Review
24 days
Class
Class II
Product code
FTD
Recalls
2
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK882613 Alm Surgical LampsAlm Surgical Equipment, Inc. · 1988
  2. Descendant · cites it directly · 2 of its ownK982063 Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 1998 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK040015 Modification to Prismalix Surgical LightAlm S.A. · 2004
  4. Descendant · 2 generations on · 0 of its ownK030906 Axcel Surgical LightAlm · 2003 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 1998 · cites it directly2descendants
  • K040015Modification to Prismalix Surgical LightAlm S.A. · 2004 · 2 generations on0descendants
  • K030906Axcel Surgical LightAlm · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882613Alm Surgical LampsAlm Surgical Equipment, Inc.1988—
+1K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc.19981
+2K040015Modification to Prismalix Surgical LightAlm S.A.2004—
+2K030906Axcel Surgical LightAlm20031

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200410
FIG. 1 — Lineage of K882613, 1988–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTD? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc.19982

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 23, 2009Not classifiedZ-1153-2009Device DesignThe screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.
Feb 23, 2009Not classifiedZ-1154-2009Device DesignThe screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K982063 (Alm Surgical Equipment, Inc., 1998) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FTD devices

FTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTD

3in 2013

2007: 12010: 22011: 12013: 3
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTD

70in 2013

2013: 70 days median
2007high 70 (2013)2026

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

Recalls per year · FTD

6in 2023

2007: 112009: 92010: 32016: 12023: 6
2007high 11 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FTD

81in 2025

2007: 72008: 102009: 222010: 212011: 302012: 262013: 292014: 292015: 452016: 182017: 102018: 162019: 802020: 1052021: 652022: 1362023: 2512024: 1442025: 81
2007high 251 (2023) · low 7 (2007)2025

MAUDE reports naming product code FTD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—117
20080—010
20090—922
20102—321
20111—030
20120—026
2013370029
20140—029
20150—045
20160—118
20170—010
20180—016
20190—080
20200—0105
20210—065
20220—0136
20230—6251
20240—0144
20250—081
20260—0—

More from Alm Surgical Equipment, Inc.

10 FDA decisions under this applicant name. See the company

  • K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 19981 recall
  • K961886Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc. · 1996
  • K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc. · 1996
  • K945102Mta:Angenieux Starpoint XE Xenon Light SourceAlm Surgical Equipment, Inc. · 1994
  • K942043Drager Dve 8000/1/2 Series Syst W/Dve 4002 and 8032EAlm Surgical Equipment, Inc. · 1994

Recent decisions in FTD

The FTD category page

  • K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013
  • K130513Volista 400; Volista 600Maquet S.A.S. · 201319 recalls
  • K123776Polaris 100/200Drager Medical GmbH · 2013
  • K111020Atricure DissectorAtriCure, Inc. · 2011
  • K100234HM-Lamp IIHillusa, Inc. · 2010

https://510kreport.com/device/K882613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882613: Alm Surgical Lamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882613

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026