510(k) Report

510(k) · Cleared

Cleared

Autologel Process Centrifuge, Model B4360 (100-103, 100-129)

K030340510(k) TraditionalCleared Apr 11, 200370-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

Cytomedix · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Cleared on Apr 11, 2003 as substantially equivalent to K991430 (Harvest Technologies, LLC, 1999) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1999.

Decided
Apr 11, 2003
Review
70 days
Class
Class I
Product code
JQC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K991430 (1999). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK991430 · Smartprep Centrifuge System · Harvest Technologies, LLC · 1999 · recalled19961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K991430 · Smartprep Centrifuge System · Harvest Technologies, LLC · 1999 · recalled0
  1. Root · 1 generation backK991430 Smartprep Centrifuge SystemHarvest Technologies, LLC · 1999 · Recalled
  2. This deviceK030340 Autologel Process Centrifuge, Model B4360 (100-103, 100-129)Cytomedix · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K991430Smartprep Centrifuge SystemHarvest Technologies, LLC19992
0 (this device)K030340Autologel Process Centrifuge, Model B4360 (100-103, 100-129)Cytomedix2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K030340, 1999–2003Source: 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), 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.

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  • 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.

TypeNumberDeviceApplicantDecidedRecalls
*K991430Smartprep Centrifuge System
Summary page 1
…centrifuges have been identified: Harvest Technologies, LLC., Smartprep Centrifugation System (K991430) and 3i Models 7426 and 7437 CelSep Centrifuge System (K994148). Device Description:…
Harvest Technologies, LLC19992
*K9941483I Model (S)7426 and 7427 Celsep Centrifuge System
Summary page 1
…Smartprep Centrifugation System (K991430) and 3i Models 7426 and 7437 CelSep Centrifuge System (K994148). Device Description: The AutoloGel Process Centrifuge consists of a Table-top,…
Implant Innovations, Inc.2000—

Also cleared against K991430: 2 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?

  • 1 of the 2 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K991430.

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—

What is it indicated for?

The AutoloGel Process Centrifuge is designed to be used at the patient’s point of care for the

safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient’s

blood (up to 60 mi).

Indications for use as stated in the FDA summary.

Also cleared against K991430

2 other devices cite the same predicate.

  • K052925SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 20062 recalls
  • K021902Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator Deisposable Kit, MKT300Medtronic Vascular · 2002

Recent decisions in JQC

The JQC category page

  • K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60…Emcyte Corporation · 2019
  • K103340SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemHarvest Technologies, Corp. · 20102 recalls
  • K081345Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)Thermogenesis Corp. · 2008
  • K071934Marrowstim Concentration Kit and Marrowstim Mini Concentration KitBiomet Manufacturing Corp · 20071 recall
  • K070666Genesiscs Component Concentrating SystemPerfusion Partners & Assoc., Inc. · 2007

https://510kreport.com/device/K030340 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030340: Autologel Process Centrifuge, Model B4360 (100-103, 100-129).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030340

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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