Cleared Traditional

K881805 - TU STOPCOCK

K881805 is the FDA 510(k) clearance for TU STOPCOCK by Tulan Corp. C/O Richard Hamer Assoc.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K881805 · Tulan Corp. C/O Richard Hamer Assoc. · General Hospital
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Oct 1988
Decision
159d
Days
Class 2
Risk

K881805 is an FDA 510(k) clearance for the TU STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Tulan Corp. C/O Richard Hamer Assoc. (Sterling, US). The FDA issued a Cleared decision on October 4, 1988 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tulan Corp. C/O Richard Hamer Assoc. devices

Submission Details

510(k) Number K881805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1988
Decision Date October 04, 1988
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 21
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K881805.
MULTI-PORT MANIFOLD
K932512 · Baxter Healthcare Corp · Feb 1994
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983