Cleared Traditional

K971066 - TAMARYN I.V. FLOW REGULATOR EXTENSION SET

K971066 is an FDA 510(k) clearance for TAMARYN I.V. FLOW REGULATOR EXTENSION SET, manufactured by Tamaryn Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K971066 · Tamaryn Medical Systems, Inc. · General Hospital
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Jun 1997
Decision
72d
Days
Class 2
Risk

K971066 is an FDA 510(k) clearance for the TAMARYN I.V. FLOW REGULATOR EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Tamaryn Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 72 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 Tamaryn Medical Systems, Inc. devices

FDA 510(k) Submission Details - K971066

510(k) Number K971066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date June 04, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 644
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