510(k) Report

510(k) · Cleared

Cleared

Cats-Clinical Lab Computer Software-

K840502510(k) TraditionalCleared Apr 4, 198458-day reviewClass I21 CFR 862.2100

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

Precision Technology, Inc. · JQP Calculator/Data Processing Module, For Clinical Use

Cleared on Apr 4, 1984 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 4, 1984
Review
58 days
Class
Class I
Product code
JQP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840502Source: 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.

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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 JQP devices

JQP Calculator/Data Processing Module, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQP

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JQP

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

Recalls per year · JQP

1in 2025

2007: 32008: 62009: 92010: 72011: 92012: 62013: 52014: 32015: 102016: 122017: 22018: 102019: 22020: 22022: 32024: 52025: 12026 (partial year): 2
2007high 12 (2016) · low 0 (2021)2026

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

Adverse event reports per year · JQP

113in 2025

2007: 222008: 92009: 142010: 452011: 1282012: 1022013: 462014: 852015: 1422016: 2042017: 1102018: 2182019: 2532020: 522021: 1052022: 1662023: 1712024: 1022025: 113
2007high 253 (2019) · low 9 (2008)2025

MAUDE reports naming product code JQP, 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—322
20080—69
20090—914
20100—745
20110—9128
20121—6102
20130—546
20140—385
20150—10142
20160—12204
20170—2110
20180—10218
20190—2253
20200—252
20210—0105
20220—3166
20230—0171
20240—5102
20250—1113
20260—2—
Cite this page

510(k) Report. “K840502: Cats-Clinical Lab Computer Software-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K840502

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