510(k) · Cleared

Cleared

Pacific Hemostasis Thromboscreen 200

K991321510(k) TraditionalCleared Jun 21, 199963-day reviewClass II21 CFR 864.5400

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

Pacific Hemostasis · KQG Instrument, Coagulation

Cleared on Jun 21, 1999 as substantially equivalent to K884863 (Medical Laboratory Automation Systems, Inc., 1989) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1989.

Decided: Jun 21, 1999
Review: 63 days
Class: Class II
Product code: KQG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K884863 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK884863 Electra 900C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc. · 1989
This deviceK991321 Pacific Hemostasis Thromboscreen 200Pacific Hemostasis · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K884863	Electra 900C Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	1989	—
0 (this device)	K991321	Pacific Hemostasis Thromboscreen 200	Pacific Hemostasis	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0

FIG. 1 — Lineage of K991321, 1989–1999Source: 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 KQG? 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? (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 …boScreen® 200 Common Name: Manual Coagulation Instrument Classification Name: Instrument, Coagulation (per 21 CFR section 864.5400) Equivalent Devices: MLA-900C &1000C, #K884863, #K894052 Description of the ThromboScreeq" 200 sed-for the performance of in- vitro diagnostic clotting procedures in the cli…	Medical Laboratory Automation Systems, Inc.	1989	—
*	K894052	Electra 1000C Automatic Coagulation Timer Summary page 1 …200 Common Name: Manual Coagulation Instrument Classification Name: Instrument, Coagulation (per 21 CFR section 864.5400) Equivalent Devices: MLA-900C &1000C, #K884863, #K894052 Description of the ThromboScreeq" 200 sed-for the performance of in- vitro diagnostic clotting procedures in the clinical labo…	Medical Laboratory Automation Systems, Inc.	1989	—

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?

None of the 2 ancestors has a recall.
5 other devices also cite its predicate K884863.

How does its category compare?

All KQG devices

KQG Instrument, Coagulation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQG

FDA has decided no KQG device since 2007.

Median 510(k) review, days · KQG

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

Recalls per year · KQG

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KQG

16in 2010

2007high 16 (2010) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	8
2010	—	1	16
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Pacific Hemostasis ThromboScreen® 200 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing in the clinical laboratory.

Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), as well as PT and APTT-based factor assays.

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/K991321 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991321: Pacific Hemostasis Thromboscreen 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991321

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026