510(k) Report

510(k) · Cleared

Cleared

Dialysis Machines DM-346 & 346-1

K772163510(k) TraditionalCleared Nov 28, 197712-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

Extracorporeal Medical Specialities, Inc. · FIJ System, Dialysate Delivery, Recirculating, Single Pass

Cleared on Nov 28, 1977 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 28, 1977
Review
12 days
Class
Class II
Product code
FIJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K772163Source: 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 FIJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 FIJ devices

FIJ System, Dialysate Delivery, Recirculating, Single Pass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIJ

FDA has decided no FIJ device since 2007.

Median 510(k) review, days · FIJ

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

Recalls per year · FIJ

No recall names FIJ since 2007.

Adverse event reports per year · FIJ

No MAUDE report names FIJ 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 Extracorporeal Medical Specialities…

69 FDA decisions under this applicant name. See the company

  • K843955Extracorporeal Maxima Hollow Fiber OxygenatorExtracorporeal Medical Specialities, Inc. · 1984
  • K840532Hemoperfusion System TP-400Extracorporeal Medical Specialities, Inc. · 1984
  • K840262Hancock Pericardial PatchExtracorporeal Medical Specialities, Inc. · 1984
  • K840146Exp* 700 Parallel Plate DialyzerExtracorporeal Medical Specialities, Inc. · 1984
  • K840057Exp* 500 Parallel Plate DialyzerExtracorporeal Medical Specialities, Inc. · 1984

https://510kreport.com/device/K772163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K772163: Dialysis Machines DM-346 & 346-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K772163

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