510(k) Report

510(k) · Cleared

Cleared

Bleeding Time Device Disposable

K830645510(k) TraditionalCleared Mar 17, 198316-day reviewClass II21 CFR 864.6100

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

American Dade · JCA Device, Bleeding Time

Cleared on Mar 17, 1983 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 17, 1983
Review
16 days
Class
Class II
Product code
JCA
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K830645Source: FDA 510(k) database · 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 JCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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?

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.

How does its category compare?

All JCA devices

JCA Device, Bleeding Time: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCA

FDA has decided no JCA device since 2007.

Median 510(k) review, days · JCA

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

Recalls per year · JCA

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JCA

2in 2014

2010: 12011: 22013: 12014: 2
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code JCA, 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—01
20110—02
20120—00
20130—11
20140—02
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from American Dade

149 FDA decisions under this applicant name. See the company

  • K873051Stratus (R) HFSH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873171Stratus (R) CK-MB Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873052Stratus (R) HLH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K872789Paramax Urine/CSF CalibratorAmerican Dade · 1987
  • K872195Data-FI Dimertest Latex AssayAmerican Dade · 1987

Recent decisions in JCA

The JCA category page

  • K911745Simplate PediatricOrganon Teknika Corp. · 1991
  • K911996Surgicutt-Bleeding Time Device, ModificationInternational Technidyne Corp. · 1991
  • K871318Q.I.C. Bleeding Time DeviceHelena Laboratories · 1987
  • K850542Surgicutt - Bleeding Time DeviceInternational Technidyne Corp. · 1985
  • K801815AutoletUlster Scientific, Inc. · 1980

https://510kreport.com/device/K830645 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830645: Bleeding Time Device Disposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830645

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026