Cleared Traditional

K901228 - MULTI-STRIP

K901228 is the FDA 510(k) clearance for MULTI-STRIP by Bellhouse Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K901228 · Bellhouse Medical, Inc. · Gastroenterology & Urology device
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May 1990
Decision
54d
Days
Class 2
Risk

K901228 is an FDA 510(k) clearance for the MULTI-STRIP. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Bellhouse Medical, Inc. (Lake Elmo, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bellhouse Medical, Inc. devices

Submission Details

510(k) Number K901228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date May 07, 1990
Days to Decision 54 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 130d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
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 - FKX System, Peritoneal, Automatic Delivery

All 46
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K901228.
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
K923065 · Baxter Healthcare Corp · Mar 1994
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NMC CYCLER MACHINE
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ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · Baxter Healthcare Corp · Jan 1989
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · Quinton, Inc. · Dec 1987