510(k) Report

FDA applicant

O.R. Solutions, Inc.

Chantilly, VA7 decisions1995–20051 recall

FDA records 7 decisions for O.R. Solutions, Inc. (Chantilly, VA) from 1995 to 2005: 7 510(k) clearances. Most are in product codes LHC (Warmer, Irrigation Solution) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided O.R. Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for O.R. Solutions, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • LHCWarmer, Irrigation Solution4decisions
  • KKXDrape, Surgical, Antimicrobial1decision
  • OCTAnti Fog Solution And Accessories, Endoscopy1decision
  • LRJDisinfectant, Medical Devices1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K021288ORS-1000LDO.R. Solutions, Inc. · 20023cite it
  • K051979Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 20052cite it
  • K023282ORS-3000LDO.R. Solutions, Inc. · 20022cite it

What has FDA decided for it lately?

  • K051979Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 2005
  • K0232831075LD Hush-SlushO.R. Solutions, Inc. · 2002
  • K023282ORS-3000LDO.R. Solutions, Inc. · 20021 recall
  • K021288ORS-1000LDO.R. Solutions, Inc. · 20021 recall
  • K021289Warmer 2000LDO.R. Solutions, Inc. · 2002
  • K960836DMS-9000O.R. Solutions, Inc. · 1996
  • K953654ORS-111O.R. Solutions, Inc. · 1995

All 7 as O.R. Solutions, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021288Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110…Aug 18, 2015Class II