Cleared Traditional

FRESENIUS VARIABLE FILL MONITOR (K921052) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921052 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Feb 1993
Decision
357d
Days
Class 2
Risk

K921052 is an FDA 510(k) clearance for the FRESENIUS VARIABLE FILL MONITOR. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on February 25, 1993 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius USA, Inc. devices

Submission Details

510(k) Number K921052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date February 25, 1993
Days to Decision 357 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 130d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 38
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K921052.
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · Baxter Healthcare Corp · Aug 1996
ABBOTT SMART CAP
K921818 · Abbott Laboratories · Mar 1994
BAXTER APD 12' EXTENSION LINE
K925403 · Baxter Healthcare Corp · Feb 1994
ABBOTT SMART CAP
K915304 · Abbott Laboratories · Feb 1992
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526 · Baxter Healthcare Corp · Nov 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · Baxter Healthcare Corp · Jan 1990