Cleared Traditional

K770916 - TYGON PAC-MONITORING LINES & FLUID ADMIN

K770916 is the FDA 510(k) clearance for TYGON PAC-MONITORING LINES & FLUID ADMIN by Norton Performance Plastics Corp.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K770916 · Norton Performance Plastics Corp. · General Hospital
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Jun 1977
Decision
29d
Days
Class 2
Risk

K770916 is an FDA 510(k) clearance for the TYGON PAC-MONITORING LINES & FLUID ADMIN. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1977 after a review of 29 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 Norton Performance Plastics Corp. devices

Submission Details

510(k) Number K770916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1977
Decision Date June 17, 1977
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 37
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K770916.
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · Cordis Corp. · Feb 1979
SUPPLEMENTAL TYGON PAC-MONITORING LINES
K780662 · Norton Performance Plastics Corp. · Jun 1978
STOPCOCK
K780596 · Abco Dealers, Inc. · Apr 1978
TYGON PAC-STOPCOCKS
K770708 · Norton Performance Plastics Corp. · Jun 1977
TYGON PAC-MONITORING LINES & FLUID ADMIN
K770707 · Norton Performance Plastics Corp. · Jun 1977