510(k) Report

510(k) · Cleared

Cleared

Double Elutra-Pack Unit

K760914510(k) TraditionalCleared Nov 23, 197627-day reviewClass II21 CFR 864.9145

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. · KSW System, Processing For Frozen Blood

Cleared on Nov 23, 1976 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 23, 1976
Review
27 days
Class
Class II
Product code
KSW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760914Source: 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 KSW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • 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?

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 KSW devices

KSW System, Processing For Frozen Blood: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KSW

FDA has decided no KSW device since 2007.

Median 510(k) review, days · KSW

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

Recalls per year · KSW

No recall names KSW since 2007.

Adverse event reports per year · KSW

2in 2017

2016: 12017: 2
2007high 2 (2017) · low 0 (2007)2025

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

https://510kreport.com/device/K760914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760914: Double Elutra-Pack Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760914

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