510(k) · Cleared

Cleared

Careside Aptt

K014028510(k) TraditionalCleared Feb 8, 200264-day reviewClass II21 CFR 864.7925

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

Careside Hemotology, Inc. · GFO Activated Partial Thromboplastin

Cleared on Feb 8, 2002 as substantially equivalent to K884863 (Medical Laboratory Automation Systems, Inc., 1989) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1976.

Decided: Feb 8, 2002
Review: 64 days
Class: Class II
Product code: GFO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K760318 (1976). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK760318 Actin, Activated Cephaloplastin ReagentDade, Baxter Travenol Diagnostics, Inc. · 1976 · Recalled
This deviceK014028 Careside ApttCareside Hemotology, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760318	Actin, Activated Cephaloplastin Reagent	Dade, Baxter Travenol Diagnostics, Inc.	1976	1
0 (this device)	K014028	Careside Aptt	Careside Hemotology, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0

FIG. 1 — Lineage of K014028, 1976–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K253957 HemosIL Silica Clotting Timescore 11.5 · 4 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K884863	Electra 900C Automatic Coagulation Timer Summary page 1 …ance Electra 900C (henceforth refered to as Electra 900C or MLA Electra 900C). Name of Predicate Device: Dade Actin on the Electra 900C. Predicate Device 510K number: K884863 (MLA Electra 900C) K760318 (Dade Actin) Product Code: 81GFO CARESIDE, Inc. CARESIDE APTT Premarket Notification P…	Medical Laboratory Automation Systems, Inc.	1989	—
*	K760318	Actin, Activated Cephaloplastin Reagent Summary page 1 …th refered to as Electra 900C or MLA Electra 900C). Name of Predicate Device: Dade Actin on the Electra 900C. Predicate Device 510K number: K884863 (MLA Electra 900C) K760318 (Dade Actin) Product Code: 81GFO CARESIDE, Inc. CARESIDE APTT Premarket Notification Page 11 December 4, 2001 1v…	Dade, Baxter Travenol Diagnostics, Inc.	1976	1

Also cleared against K884863: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 2 ancestors has a recall of any class.
5 other devices also cite its predicate K884863.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	7
2012	0	—	0	0
2013	0	—	1	3
2014	0	—	0	2
2015	0	—	0	2
2016	1	—	0	3
2017	0	—	0	19
2018	0	—	2	4
2019	0	—	0	1
2020	1	—	0	0
2021	0	—	0	11
2022	0	—	0	0
2023	0	—	0	3
2024	0	—	0	2
2025	0	—	1	14
2026	1	—	0	—

What is it indicated for?

For in vitro diagnostic use with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or citrated plasma as an aid in the diagnosis of patients with clotting disorders and to monitor patients receiving heparin anticoagulation therapy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014028: Careside Aptt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014028

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026