510(k) Report

FDA applicant

Sunrise Medical Hhg, Inc.

Somerset, PA10 decisions1998–20086 recalls

FDA records 10 decisions for Sunrise Medical Hhg, Inc. (Somerset, PA) from 1998 to 2008: 10 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and JCX (Apparatus, Suction, Ward Use, Portable…). Its devices cite 9 predicates, 0 of them its own earlier devices. 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007: 22008: 22013: 12016: 1
2007high 2 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Sunrise Medical Hhg, 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?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2decisions
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision
  • ITIWheelchair, Powered1decision
  • CAFNebulizer (Direct Patient Interface)1decision
  • BZDVentilator, Non-Continuous (Respirator)1decision
  • CAWGenerator, Oxygen, Portable1decision

Also: NFB (1), MNR (1), BTA (1).

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 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.

  • K982304Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 19988cite it
  • K991722Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 19993cite it
  • K020329Devilbiss PD1000Sunrise Medical Hhg, Inc. · 20023cite it
  • K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 20022cite it
  • K003626Devilbiss HumidifierSunrise Medical Hhg, Inc. · 20011cites it
  • K083249Quickie RhythmSunrise Medical Hhg, Inc. · 20081cites it

What has FDA decided for it lately?

  • K083249Quickie RhythmSunrise Medical Hhg, Inc. · 2008
  • K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002
  • K020329Devilbiss PD1000Sunrise Medical Hhg, Inc. · 20022 recalls
  • K020900Devilbiss Model 9200D Heated Humidifier SystemSunrise Medical Hhg, Inc. · 2002
  • K011229Devilbiss 9000 Series Cpap, Model 9001Sunrise Medical Hhg, Inc. · 2001
  • K003626Devilbiss HumidifierSunrise Medical Hhg, Inc. · 2001
  • K993492Devilbiss Nebulizer Model 800Sunrise Medical Hhg, Inc. · 2000
  • K991722Devilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. · 19991 recall

All 10 as Sunrise Medical Hhg, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K982304DeVilbiss Model 7305P-D Powered Suction UnitMay 23, 2016Class II
  • K982304DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP…Mar 7, 2013Class II
  • K991722DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow…Oct 30, 2008
  • K982304DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or…Oct 27, 2008
  • K020329535D-X CF Continuous Flow CylinderJan 24, 2007
  • K020329DeVilbiss PD1000A Pulse Dose Oxygen Conserving CylinderJan 24, 2007

Other applicant names beginning “Sunrise”

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

Sunrise Medical, Inc. 33Sunrise Technologies, Inc. 19Sunrise Medical (Us), LLC 5Sunrise Medical Quickie Designs, Inc. 4Sunrise SA 3Sunrise International Business 1