510(k) Report

510(k) · Cleared

Cleared

General Purpose Centrifuge

K864974510(k) TraditionalCleared Jan 9, 198721-day reviewClass I21 CFR 862.2050

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

Norfolk Scientific, Inc. · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Cleared on Jan 9, 1987 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 9, 1987
Review
21 days
Class
Class I
Product code
JQC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K864974Source: 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 JQC? 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 JQC devices

JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQC

1in 2019

2007: 22008: 12010: 12019: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JQC

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

Recalls per year · JQC

3in 2019

2009: 22010: 22011: 12014: 12017: 22019: 32026 (partial year): 2
2007high 3 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JQC

6in 2025

2007: 62008: 72009: 52010: 72011: 402012: 182013: 262014: 1122015: 1302016: 702017: 312018: 102019: 72020: 42021: 12022: 12023: 42024: 22025: 6
2007high 130 (2015) · low 1 (2021)2025

MAUDE reports naming product code JQC, 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
20072—06
20081—07
20090—25
20101—27
20110—140
20120—018
20130—026
20140—1112
20150—0130
20160—070
20170—231
20180—010
20191—37
20200—04
20210—01
20220—01
20230—04
20240—02
20250—06
20260—2—
Cite this page

510(k) Report. “K864974: General Purpose Centrifuge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864974

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