Cleared Traditional

K771387 - MONITORING LINES & FLUID ADMIN.

K771387 is an FDA 510(k) clearance for MONITORING LINES & FLUID ADMIN., manufactured by Norton Performance Plastics Corp.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K771387 · Norton Performance Plastics Corp. · General Hospital
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Aug 1977
Decision
26d
Days
Class 2
Risk

K771387 is an FDA 510(k) clearance for the MONITORING LINES & FLUID ADMIN.. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Walker, US). The FDA issued a Cleared decision on August 22, 1977 after a review of 26 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 - K771387

510(k) Number K771387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1977
Decision Date August 22, 1977
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

Product Code FPK Tubing, Fluid Delivery
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 - FPK Tubing, Fluid Delivery

All 63
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K771387.
NASAL GASTRIC TUBE RETAINER
K780396 · Mor-Mac, Inc. · Mar 1978
TIME WATCH
K772119 · Akzona, Inc. · Nov 1977
BLOOD COLLECTION SET TYPE H
K771269 · Berman, Pcp & Consultants, Inc. · Sep 1977
POUCH, TYVEK-POLYMYLON
K770945 · Medical Disposables Intl., Inc. · Jun 1977
CONNECTORS
K770596 · Abco Dealers, Inc. · Jun 1977
LUER-LOCK EXTENSION SET
K770174 · American Viggo · Mar 1977
K771387 · MONITORING LINES & FLUID ADMIN.
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