510(k) Report

FDA applicant

Alm Surgical Equipment, Inc.

Anaheim, CA10 decisions1988–19983 recalls

FDA records 10 decisions for Alm Surgical Equipment, Inc. (Anaheim, CA) from 1988 to 1998: 10 510(k) clearances. Most are in product codes FQO (Table, Operating-Room, Ac-Powered) and FSQ (Light, Surgical, Instrument). Its devices cite 8 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Alm Surgical Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alm Surgical Equipment, Inc. since 2007.

Recalls per year

1in 2023

2009: 22023: 1
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Alm Surgical Equipment, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alm Surgical Equipment, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FQOTable, Operating-Room, Ac-Powered4decisions
  • FSQLight, Surgical, Instrument2decisions
  • FFSImage, Illumination, Fiberoptic, For Endoscope1decision
  • FSYLight, Surgical, Ceiling Mounted1decision
  • FWXTable, Operating-Room, Mechanical1decision
  • FTDLamp, Surgical1decision

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K921297Drager Dve 4000 Series SystemAlm Surgical Equipment, Inc. · 19922cite it
  • K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 19982cite it
  • K942043Drager Dve 8000/1/2 Series Syst W/Dve 4002 and 8032EAlm Surgical Equipment, Inc. · 19941cites it
  • K882613Alm Surgical LampsAlm Surgical Equipment, Inc. · 19881cites it

What has FDA decided for it lately?

  • 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
  • K922409Alm Illuminator Series Light SystemAlm Surgical Equipment, Inc. · 1993
  • K921297Drager Dve 4000 Series SystemAlm Surgical Equipment, Inc. · 1992
  • K921848BFW Wehmerlite IV-a Fiber Optic Surg. HeadlightAlm Surgical Equipment, Inc. · 1992

All 10 as Alm Surgical Equipment, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K982063Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 -…Nov 8, 2023Class II
  • K882613ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are…Feb 23, 2009
  • K882613Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are…Feb 23, 2009