510(k) Report

510(k) · Cleared

Cleared

Stratus Myoglobin Fluorometric Enzyme Immunoassay

K922125510(k) TraditionalCleared Jul 21, 199276-day reviewClass II21 CFR 866.5680

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

Baxter Diagnostics, Inc. · DDR Myoglobin, Antigen, Antiserum, Control

Cleared on Jul 21, 1992 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 21, 1992
Review
76 days
Class
Class II
Product code
DDR
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK922125 Stratus Myoglobin Fluorometric Enzyme ImmunoassayBaxter Diagnostics, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK965213 Stratus Myoglobin Gluorometric Enzyme ImmunoassayDade Intl., Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K965213Stratus Myoglobin Gluorometric Enzyme ImmunoassayDade Intl., Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922125Stratus Myoglobin Fluorometric Enzyme ImmunoassayBaxter Diagnostics, Inc.1992—
+1K965213Stratus Myoglobin Gluorometric Enzyme ImmunoassayDade Intl., Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K922125, 1992–1997Source: 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 DDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DDR device

  1. #1 K231832 Access Myoglobinscore 6.3 · 2 generations · no Class I recall
Get a 510(k) Report

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? (1)

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

NumberDeviceApplicantDecidedDescendants
K965213Stratus Myoglobin Gluorometric Enzyme ImmunoassayDade Intl., Inc.19970

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, K965213 (Dade Intl., Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DDR devices

DDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DDR

1in 2023

2009: 22012: 12013: 12023: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DDR

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

Recalls per year · DDR

2in 2015

2007: 22009: 12015: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DDR

5in 2025

2009: 32011: 52012: 22013: 32014: 12016: 32017: 52018: 32019: 62020: 22021: 12022: 12023: 72024: 312025: 5
2007high 31 (2024) · low 0 (2007)2025

MAUDE reports naming product code DDR, 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—20
20080—00
20092—13
20100—00
20110—05
20121—02
20131—03
20140—01
20150—20
20160—03
20170—05
20180—03
20190—06
20200—02
20210—01
20220—01
20231—07
20240—031
20250—05
20260—0—

More from Baxter Diagnostics, Inc.

72 FDA decisions under this applicant name. See the company

  • K934458Dried Gram-Positive Mic/Combo PanelsBaxter Diagnostics, Inc. · 1995
  • K950817Dried Gram Positive Mic/Combo Panels/PneumococciBaxter Diagnostics, Inc. · 1995
  • K935704Dried Gram-Negative Mic//Combo PanelsBaxter Diagnostics, Inc. · 1995
  • K950570Stratus Progesterone Fluorometric Enzyme ImmunoassayBaxter Diagnostics, Inc. · 1995
  • K945235Dried Gram-Positive Mic/Combo PanelsBaxter Diagnostics, Inc. · 1995

Recent decisions in DDR

The DDR category page

  • K231832Access MyoglobinBeckman Coulter, Inc. · 2023
  • K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013
  • K122599Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. · 20121 recall
  • K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009
  • K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc. · 2009

https://510kreport.com/device/K922125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922125: Stratus Myoglobin Fluorometric Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922125

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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