510(k) Report

510(k) · Cleared

Cleared

Sterile, Disposable Centrifuge Bowl

K791106510(k) TraditionalCleared Aug 10, 197958-day reviewClass II21 CFR 864.9245

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

Travenol Laboratories, S.A. · GKT Separator, Automated, Blood Cell, Diagnostic

Cleared on Aug 10, 1979 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 10, 1979
Review
58 days
Class
Class II
Product code
GKT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791106Source: 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 GKT? 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 GKT device

  1. #1 K200530 AMICUS Separator Systemscore 0.9 · 4 generations · 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?

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 GKT devices

GKT Separator, Automated, Blood Cell, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKT

1in 2020

2016: 12020: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKT

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

Recalls per year · GKT

No recall names GKT since 2007.

Adverse event reports per year · GKT

229in 2025

2007: 82008: 42009: 162010: 112011: 772012: 5512013: 4602014: 3712015: 3572016: 4402017: 3272018: 3542019: 4342020: 5612021: 4902022: 4452023: 3432024: 4442025: 229
2007high 561 (2020) · low 4 (2008)2025

MAUDE reports naming product code GKT, 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—08
20080—04
20090—016
20100—011
20110—077
20120—0551
20130—0460
20140—0371
20150—0357
20161—0440
20170—0327
20180—0354
20190—0434
20201—0561
20210—0490
20220—0445
20230—0343
20240—0444
20250—0229
20260—0—

More from Travenol Laboratories, S.A.

206 FDA decisions under this applicant name. See the company

  • K874181Baxter Bedside SystemTravenol Laboratories, S.A. · 1988
  • K873894Continu-Flo Solution W/Check Valve 2 Y-Inject SiteTravenol Laboratories, S.A. · 1987
  • K873873Resubmitted Micron Transfusion FilterTravenol Laboratories, S.A. · 1987
  • K873984Automatic Peritoneal Dialysis Cycler Set (5C4437)Travenol Laboratories, S.A. · 1987
  • K872364Hemodialysis (SPS), Model 550, Code 5M1309Travenol Laboratories, S.A. · 19872 recalls

Recent decisions in GKT

The GKT category page

  • K200530AMICUS Separator SystemFresenius Kabi AG · 2020
  • K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc · 2016
  • K822521Automated Blood Cell SeparatorCryosan, Inc. · 1982
  • K820396Automated Blood Cell Separ. Disp. SftwrPheragen Technology Corp. · 1982
  • K801233Celltrifuge IITravenol Laboratories, S.A. · 1980

https://510kreport.com/device/K791106 · printed Nov 3, 2026

Cite this page

510(k) Report. “K791106: Sterile, Disposable Centrifuge Bowl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K791106

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