510(k) Report

510(k) · Cleared

Cleared

The Vita 2 Disposable Dialyzer

K801634510(k) TraditionalCleared Dec 17, 1980155-day reviewClass II21 CFR 876.5820

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

Bellco Artifidial Organ Spec., Inc. · FHS Dialyzer, Single Coil

Cleared on Dec 17, 1980 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 17, 1980
Review
155 days
Class
Class II
Product code
FHS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801634Source: 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 FHS? 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 FHS devices

FHS Dialyzer, Single Coil: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHS

FDA has decided no FHS device since 2007.

Median 510(k) review, days · FHS

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

Recalls per year · FHS

No recall names FHS since 2007.

Adverse event reports per year · FHS

No MAUDE report names FHS since 2007.

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—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Bellco Artifidial Organ Spec., Inc.

3 FDA decisions under this applicant name. See the company

  • K801633The Bravo New Parallel Flow DialyzerBellco Artifidial Organ Spec., Inc. · 1980
  • K801632The Bellco Fistula NeedlesBellco Artifidial Organ Spec., Inc. · 1980

Recent decisions in FHS

The FHS category page

  • K812811Microcoil 80 DialyzerErika, Inc. · 1981
  • K811974Microcoil 150 DialyzerErika, Inc. · 1981
  • K800723Micro-Coil 100 Coil DialyzerErika, Inc. · 1980
  • K800174Gambro Lundia Coil DialyzerGambro, Inc. · 1980
  • K790223Dialyzer, CD-800 CoilTravenol Laboratories, S.A. · 1979

https://510kreport.com/device/K801634 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801634: The Vita 2 Disposable Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801634

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