Cleared Traditional

AUTO SASH (TM) (K904663) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904663 · Block Medical, Inc. · General Hospital
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Nov 1992
Decision
773d
Days
Class 2
Risk

K904663 is an FDA 510(k) clearance for the AUTO SASH (TM). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Block Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 773 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Block Medical, Inc. devices

Submission Details

510(k) Number K904663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1990
Decision Date November 23, 1992
Days to Decision 773 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
644d slower than avg
Panel avg: 129d · This submission: 773d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K904663.
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INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · Baxter Healthcare Corp · Apr 1993
LIFESHIELD ANESTHESIA SET
K913982 · Abbott Laboratories · Nov 1992
INTERLINK(TM) INJECTION SITE
K922558 · Baxter Healthcare Corp · Oct 1992
MERIT ADMINISTRATION SET
K915678 · Merit Medical Systems, Inc. · Jul 1992