510(k) Report

FDA applicant

Sunrise Medical, Inc.

Longmont, CO33 decisions1992–201320 recalls

FDA records 33 decisions for Sunrise Medical, Inc. (Longmont, CO) from 1992 to 2013: 33 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and IOR (Wheelchair, Mechanical). Its devices cite 21 predicates, 5 of them its own earlier devices. 20 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Sunrise Medical”.

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

FDA decisions per year

1in 2013

2007: 32008: 22009: 12010: 12013: 1
2007high 3 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12008: 22009: 12011: 12012: 22013: 12014: 32015: 22016: 12022: 12023: 12025: 1, 1 Class I
2007high 3 (2014) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Sunrise 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?

  • ITIWheelchair, Powered10decisions
  • IORWheelchair, Mechanical9decisions
  • BZDVentilator, Non-Continuous (Respirator)6decisions
  • CAWGenerator, Oxygen, Portable3decisions
  • INIVehicle, Motorized 3-Wheeled1decision
  • FNMMattress, Air Flotation, Alternating Pressure1decision

Also: MNS (1), FRN (1), CAF (1).

Whose devices does it build on?

Its devices cite 21 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 42 times; 5 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.

  • K123975Quickie & Zippie SeriesSunrise Medical · 20134cite it
  • K071689Devilbiss Intellipap Model DV 5 SeriesSunrise Medical · 20074cite it
  • K952641Quickie TSRSunrise Medical, Inc. · 19954cite it
  • K082209Devilbiss DV5M Smartlink SystemSunrise Medical · 20083cite it
  • K974820Breezy SeriesSunrise Medical, Inc. · 19983cite it
  • K032056Bilevel Cpap, Model 9055 SeriesSunrise Medical · 20043cite it

What has FDA decided for it lately?

  • K123975Quickie & Zippie SeriesSunrise Medical · 20135 recalls
  • K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical · 2010
  • K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical · 20091 recall
  • K082209Devilbiss DV5M Smartlink SystemSunrise Medical · 2008
  • K081468Devilbiss Portable Oxygen Concentrator, 306 SeriesSunrise Medical · 2008
  • K071397Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesSunrise Medical · 20071 Class I recall
  • K072153Quickie QX Manual Folding WheelchairSunrise Medical, Inc. · 2007
  • K071689Devilbiss Intellipap Model DV 5 SeriesSunrise Medical · 20072 recalls

All 19 as Sunrise Medical, Inc. →All 14 as Sunrise Medical →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K071397iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power…Apr 11, 2025Class I
  • K071397DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK…Mar 9, 2023Class II
  • K071397DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-QNov 18, 2022Class II
  • K123975Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of…Jul 1, 2016Class II
  • K123975Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO…Jul 27, 2015Class II
  • K123975Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO…Jul 27, 2015Class II

Other applicant names beginning “Sunrise”

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

Sunrise Technologies, Inc. 19Sunrise Medical Hhg, Inc. 10Sunrise Medical (Us), LLC 5Sunrise Medical Quickie Designs, Inc. 4Sunrise SA 3Sunrise International Business 1