Cleared Traditional

K780364 - MANIFOLD KIT

K780364 is an FDA 510(k) clearance for MANIFOLD KIT, manufactured by Spica, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K780364 · Spica, Inc. · Anesthesiology device
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Mar 1978
Decision
24d
Days
Class 1
Risk

K780364 is an FDA 510(k) clearance for the MANIFOLD KIT. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Spica, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1978 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - the FDA anesthesiology and respiratory 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 - K780364

510(k) Number K780364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1978
Decision Date March 30, 1978
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAN Regulator, Pressure, Gas Cylinder

All 26
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K780364.
MS-303-OXYGEN REGULATOR SHIELD
K810679 · Instrumentation Industries, Inc. · Apr 1981
REGULATOR, OXYGEN MECHANICAL
K803207 · Timeter Instrument Corp. · Jan 1981
EMERG. OXYGEN KIT #65350 & #65399 CASE
K802644 · B & F Medical Products, Inc. · Dec 1980
PORT-A-BOUT 240
K772216 · Hudson Oxygen Therapy Sales Co. · Jan 1978
K780364 · MANIFOLD KIT
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