510(k) Report

510(k) · Cleared

Cleared

Biotrend Oxygen Saturation & Hematocrit System

K954501510(k) TraditionalCleared Jan 16, 1996110-day reviewClass II21 CFR 870.4410

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

Medtronic Bio-Medicus, Inc. · DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Cleared on Jan 16, 1996 after a 110-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
Jan 16, 1996
Review
110 days
Class
Class II
Product code
DTY
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954501 Biotrend Oxygen Saturation & Hematocrit SystemMedtronic Bio-Medicus, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK093650 Biotrend Oxygen Saturation and Hematocrit SystemMedtronic, Inc. · 2010
  3. Descendant · 2 generations on · 0 of its ownK133157 Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda…Medtronic, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K093650Biotrend Oxygen Saturation and Hematocrit SystemMedtronic, Inc. · 2010 · cites it directly1descendant
  • K133157Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…Medtronic, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954501Biotrend Oxygen Saturation & Hematocrit SystemMedtronic Bio-Medicus, Inc.1996—
+1K093650Biotrend Oxygen Saturation and Hematocrit SystemMedtronic, Inc.2010—
+2K133157Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive…Medtronic, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201410
FIG. 1 — Lineage of K954501, 1996–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DTY? 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)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093650Biotrend Oxygen Saturation and Hematocrit SystemMedtronic, Inc.20101

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, K093650 (Medtronic, Inc., 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DTY devices

DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTY

1in 2010

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

2026 to Oct 25, outlined.

Median 510(k) review, days · DTY

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

Recalls per year · DTY

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DTY

3in 2015

2010: 1302011: 1582012: 202013: 182014: 82015: 3
2007high 158 (2011) · low 0 (2007)2025

MAUDE reports naming product code DTY, 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—00
20101—2130
20110—0158
20120—020
20130—018
20140—08
20150—03
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medtronic Bio-Medicus, Inc.

13 FDA decisions under this applicant name. See the company

  • K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998
  • K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc. · 1998
  • K941922Medsat Oxygen Saturation SystemMedtronic Bio-Medicus, Inc. · 1995
  • K936091Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerMedtronic Bio-Medicus, Inc. · 1994
  • K941921Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550Medtronic Bio-Medicus, Inc. · 19941 recall

Recent decisions in DTY

The DTY category page

  • K093650Biotrend Oxygen Saturation and Hematocrit SystemMedtronic, Inc. · 2010
  • K963698CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4International Biophysics Corp. · 1997
  • K902654Cdi (TM) System 100 Monitoring System3M Health Care, Ltd. · 19905 recalls
  • K900860Perfusion MonitorCardio Metrics, Inc. · 1990
  • K864703Modified Gas-Stat (TM) Monitoring SystemCardiovascular Devices, Inc. · 1987

https://510kreport.com/device/K954501 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954501: Biotrend Oxygen Saturation & Hematocrit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954501

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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