Cleared Traditional

I.V. WATCH (K854172) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854172 · Alltek, Inc. · General Hospital
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Dec 1985
Decision
51d
Days
Class 2
Risk

K854172 is an FDA 510(k) clearance for the I.V. WATCH. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Alltek, Inc. (Nevada City, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 Alltek, Inc. devices

Submission Details

510(k) Number K854172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date December 05, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPB Filter, Infusion Line

All 97
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K854172.
Filter Needle for Single Use
K233277 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · Baxter Healthcare Corp · Dec 2011
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · Abbott Laboratories · Aug 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869 · Baxter Healthcare Corp · Apr 1994
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
K933294 · Aesculap, Inc. · Feb 1994
FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
K932301 · Baxter Healthcare Corp · Nov 1993