510(k) Report

FDA applicant

Aspen Laboratories, Inc.

Mchenry, IL55 decisions1976–19986 recalls

FDA records 55 decisions for Aspen Laboratories, Inc. (Mchenry, IL) from 1976 to 1998: 55 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and EQH (Source, Carrier, Fiberoptic Light). 6 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 Aspen Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aspen Laboratories, Inc. since 2007.

Recalls per year

5in 2017

2012: 12017: 5
2007high 5 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Aspen Laboratories, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories24decisions
  • EQHSource, Carrier, Fiberoptic Light10decisions
  • KCYTourniquet, Pneumatic5decisions
  • FCTHeadlight, Fiberoptic Focusing2decisions
  • DRXElectrode, Electrocardiograph2decisions
  • HBIIlluminator, Fiberoptic, Surgical Field2decisions

Also: HRX (1), FWF (1), FZX (1), GEX (1), FSE (1), FQM (1).

Who builds on its devices?

Later devices cite its devices 8 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.

  • K953007Excalibur Plus Electrosurgical UnitAspen Laboratories, Inc. · 19952cite it
  • K963088Sheath, Electrosurgical PencilAspen Laboratories, Inc. · 19962cite it
  • K981220System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 19982cite it
  • K780977Single Use Blade ElectrodeAspen Laboratories, Inc. · 19781cites it
  • K780976Single Use Ball ElectrodeAspen Laboratories, Inc. · 19781cites it

What has FDA decided for it lately?

  • K981220System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1998
  • K963088Sheath, Electrosurgical PencilAspen Laboratories, Inc. · 19965 recalls
  • K955834System 6500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1996
  • K9602964000 ETMAspen Laboratories, Inc. · 1996
  • K953081Beamer PlusAspen Laboratories, Inc. · 1995
  • K953007Excalibur Plus Electrosurgical UnitAspen Laboratories, Inc. · 1995
  • K946104Smokievac Electrosurgical PencilAspen Laboratories, Inc. · 1995
  • K944012Electrosurgical Flexible Electrode in-Line Suction CoagulatorAspen Laboratories, Inc. · 1994

All 55 as Aspen Laboratories, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K963088Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…Feb 28, 2017Class II
  • K963088Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…Feb 28, 2017Class II
  • K963088Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…Feb 28, 2017Class II
  • K963088Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in…Feb 28, 2017Class II
  • K963088HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single…Feb 28, 2017Class II
  • K790770CONMED (R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No.…Dec 27, 2012Class II

Other applicant names beginning “Aspen”

FDA records each applicant name separately; these may or may not be the same firm.

Aspen Labs 6Aspen Glove Sdn. Bhd. 4Aspen Surgical Products, Inc. 2Aspen Laser Systems, LLC 2Aspen Imaging Healthcare, Inc. 2Aspen Medical, Ltd. 1