510(k) Report

510(k) · Cleared

Cleared

Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option

K002528510(k) SpecialCleared Aug 31, 200015-day reviewClass II21 CFR 864.7140

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

Sienco, Inc. · JBP Activated Whole Blood Clotting Time

Cleared on Aug 31, 2000 after a 15-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
Aug 31, 2000
Review
15 days
Class
Class II
Product code
JBP
Recalls
None
Predicates
0

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

Descendants, by year cleared 2023: 1 descendant cleared200020052010201520202025
  1. This deviceK002528 Sonoclot Coagulation & Platelet Function Analyzer System with…Sienco, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK223635 Sonoclot Coagulation & Platelet Function Analyzer System with…Sienco, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002528Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer…Sienco, Inc.2000—
+1K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K002528, 2000–2023Source: 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 JBP? 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 JBP device

  1. #1 K223635 Sonoclot Coagulation & Platelet Function…score 4.6 · 1 generation · 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
K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.20230

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, K223635 (Sienco, Inc., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JBP devices

JBP Activated Whole Blood Clotting Time: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBP

1in 2023

2007: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JBP

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

Recalls per year · JBP

2in 2025

2009: 32010: 32025: 2
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JBP

18in 2025

2007: 52008: 62009: 292010: 242011: 112012: 252013: 322014: 32015: 262016: 42017: 162018: 12019: 152020: 102021: 92022: 72023: 162024: 232025: 18
2007high 32 (2013) · low 1 (2018)2025

MAUDE reports naming product code JBP, 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
20071—05
20080—06
20090—329
20100—324
20110—011
20120—025
20130—032
20140—03
20150—026
20160—04
20170—016
20180—01
20190—015
20200—010
20210—09
20220—07
20231—016
20240—023
20250—218
20260—0—

More from Sienco, Inc.

5 FDA decisions under this applicant name. See the company

  • K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc. · 2023
  • K032952Aiact KitSienco, Inc. · 2003
  • K984141Gbact + KitSienco, Inc. · 1999
  • K952560Sonoclot Coagulation & Platelet Function AnalyzerSienco, Inc. · 1995

Recent decisions in JBP

The JBP category page

  • K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc. · 2023
  • K062604Rapidteg Teg-Act TestHaemoscope Corp. · 2007
  • K032952Aiact KitSienco, Inc. · 2003
  • K023582I-Stat Kaolin Act TestI-Stat Corporation · 20032 recalls
  • K020914Actalyke XL Activated Clotting Time Analyzer, Model 5770Helena Laboratories · 2002

https://510kreport.com/device/K002528 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002528: Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002528

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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