510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Actin, Activated Cephaloplastin Reagent

K760318510(k) TraditionalCleared Aug 3, 19768-day reviewClass II21 CFR 864.7925Recalls 1

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

Dade, Baxter Travenol Diagnostics, Inc. · GFO Activated Partial Thromboplastin

Cleared on Aug 3, 1976 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Aug 3, 1976
Review
8 days
Class
Class II
Product code
GFO
Recalls
1
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared19801990200020102020
  1. This deviceK760318 Actin, Activated Cephaloplastin ReagentDade, Baxter Travenol Diagnostics, Inc. · 1976
  2. Descendant · cites it directly · 0 of its ownK014028 Careside ApttCareside Hemotology, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K014028Careside ApttCareside Hemotology, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K760318Actin, Activated Cephaloplastin ReagentDade, Baxter Travenol Diagnostics, Inc.1976—
+1K014028Careside ApttCareside Hemotology, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K760318, 1976–2002Source: 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 GFO? 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 GFO device

  1. #1 K253957 HemosIL Silica Clotting Timescore 11.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
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
K014028Careside ApttCareside Hemotology, Inc.20020

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 25, 2015Class IIZ-1703-2015Under Investigation by firmRecovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K014028 (Careside Hemotology, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GFO devices

GFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFO

1in 2020

2016: 12020: 12026 (partial year): 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GFO

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

Recalls per year · GFO

1in 2025

2013: 12018: 22025: 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · GFO

14in 2025

2011: 72013: 32014: 22015: 22016: 32017: 192018: 42019: 12021: 112023: 32024: 22025: 14
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code GFO, 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
20100—00
20110—07
20120—00
20130—13
20140—02
20150—02
20161—03
20170—019
20180—24
20190—01
20201—00
20210—011
20220—00
20230—03
20240—02
20250—114
20261—0—

More from Dade, Baxter Travenol Diagnostics, Inc.

44 FDA decisions under this applicant name. See the company

  • K800296Whole Blood Gas Control, Levels 1,2,&3Dade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792606Whole Blood Platelet Control Normal,Dade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792723Blood Fluid FiltersDade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792607T3 Uptake (T3U) ReagentsDade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792443TSH RadioimmunoassayDade, Baxter Travenol Diagnostics, Inc. · 1979

Recent decisions in GFO

The GFO category page

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  • K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016
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  • K060688Hemosil SynthasilInstrumentation Laboratory CO · 20061 recall

https://510kreport.com/device/K760318 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760318: Actin, Activated Cephaloplastin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760318

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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