510(k) Report

FDA applicant

Cheetah Medical, Inc.

Gaithersburg, MD7 decisions2002–20111 recall

FDA records 7 decisions for Cheetah Medical, Inc. (Gaithersburg, MD) from 2002 to 2011: 7 510(k) clearances. Most are in product codes DXG (Computer, Diagnostic, Pre-Programmed…) and DSB (Plethysmograph, Impedance). Its devices cite 11 predicates, 6 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, cardiovascular panel, where it files most

How often FDA has decided Cheetah Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 32010: 12011: 1
2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cheetah Medical, 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?

  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function3decisions
  • DSBPlethysmograph, Impedance3decisions
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 11 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 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.

  • K083093Cheetah ReliantCheetah Medical, Inc. · 20083cite it
  • K042144NICOMCheetah Medical, Inc. · 20042cite it
  • K071631Nicom ElectrodesCheetah Medical, Inc. · 20081cites it
  • K072662Cheetah Reliant, Cheetah ActiveCheetah Medical, Inc. · 20081cites it
  • K103166Cheetah ReliantCheetah Medical, Inc. · 20111cites it
  • K101487Cheetah Nicom SystemCheetah Medical, Inc. · 20101cites it

What has FDA decided for it lately?

  • K103166Cheetah ReliantCheetah Medical, Inc. · 2011
  • K101487Cheetah Nicom SystemCheetah Medical, Inc. · 2010
  • K083093Cheetah ReliantCheetah Medical, Inc. · 20081 recall
  • K071631Nicom ElectrodesCheetah Medical, Inc. · 2008
  • K072662Cheetah Reliant, Cheetah ActiveCheetah Medical, Inc. · 2008
  • K042144NICOMCheetah Medical, Inc. · 2004
  • K023370Cheetah I.V.D.S., Model 2002PCheetah Medical, Inc. · 2002

All 7 as Cheetah Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083093Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5…Sep 2, 2022Class III