Cleared Traditional

K853184 - PIGGYMATE I.V. TUBING LOCK

K853184 is an FDA 510(k) clearance for PIGGYMATE I.V. TUBING LOCK, manufactured by Trend Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K853184 · Trend Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
14d
Days
Class 2
Risk

K853184 is an FDA 510(k) clearance for the PIGGYMATE I.V. TUBING LOCK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Trend Medical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 13, 1985 after a review of 14 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.

FDA 510(k) Submission Details - K853184

510(k) Number K853184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date August 13, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 1177
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K853184.
JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION
K853327 · Jufrey Multimed Corp. · Aug 1985
SECONDARY ADMINISTRATION SET
K853086 · Lyphomed, Inc. · Aug 1985
VENTED SECONDARY IV ADMINISTRATION SET
K852881 · Lyphomed, Inc. · Aug 1985
WINGED INFUSION SETS
K852989 · An-Med Intl. · Jul 1985
INTRAVENOUS INJECTION SET
K852361 · The West Co., Inc. · Jul 1985
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · Y · Jun 1985
K853184 · PIGGYMATE I.V. TUBING LOCK
Download PDF Trend Medical, Inc.