510(k) Report

510(k) · Cleared

Cleared

Ohmeda Biox 3700 Pulse Oximeter

K850494510(k) TraditionalCleared Mar 28, 198548-day reviewClass II21 CFR 870.2710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ohmeda Medical · DPZ Oximeter, Ear

Cleared on Mar 28, 1985 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 28, 1985
Review
48 days
Class
Class II
Product code
DPZ
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2001: 1 descendant cleared1990200020102020
  1. This deviceK850494 Ohmeda Biox 3700 Pulse OximeterOhmeda Medical · 1985
  2. Descendant · cites it directly · 0 of its ownK012333 Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK982728 Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001 · cites it directly0descendants
  • K982728Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K850494Ohmeda Biox 3700 Pulse OximeterOhmeda Medical1985—
+1K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc.2001—
+1K982728Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
FIG. 1 — Lineage of K850494, 1985–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc.20010
K982728Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc.19980

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012333 (Epic Medical Equipment Services, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DPZ devices

DPZ Oximeter, Ear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPZ

FDA has decided no DPZ device since 2007.

Median 510(k) review, days · DPZ

Too few DPZ 510(k)s in any year since 2007 to give a median.

Recalls per year · DPZ

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPZ

1in 2025

2009: 12010: 12011: 132012: 42013: 222014: 432015: 62016: 52017: 42018: 42019: 22021: 12022: 22024: 12025: 1
2007high 43 (2014) · low 0 (2007)2025

MAUDE reports naming product code DPZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—11
20110—113
20120—04
20130—022
20140—043
20150—06
20160—05
20170—04
20180—04
20190—02
20200—00
20210—01
20220—02
20230—00
20240—01
20250—01
20260—0—

More from Ohmeda Medical

120 FDA decisions under this applicant name. See the company

  • K123309Giraffe and Panda WarmersOhmeda Medical · 20133 Class I recalls
  • K101788Giraffe OmnibedOhmeda Medical · 20103 Class I recalls
  • K101778Giraffe IncubatorOhmeda Medical · 20101 Class I recall
  • K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 20091 Class I recall
  • K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 20071 recall

Recent decisions in DPZ

The DPZ category page

  • K042675Flexi-Stat SP02 Ear SensorElekon Industries U.S.A., Inc. · 2004
  • K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 20043 Class I recalls
  • K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • K010718Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994

https://510kreport.com/device/K850494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850494: Ohmeda Biox 3700 Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850494

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026