Cleared Traditional

K841264 - BABYSET TM & PAC TM -PULMONARY ASSIST

K841264 is the FDA 510(k) clearance for BABYSET TM & PAC TM -PULMONARY ASSIST by Life Design Systems, Inc.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K841264 · Life Design Systems, Inc. · Anesthesiology device
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Jun 1984
Decision
81d
Days
Class 1
Risk

K841264 is an FDA 510(k) clearance for the BABYSET TM & PAC TM -PULMONARY ASSIST. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Life Design Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1984 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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.

View all Life Design Systems, Inc. devices

Submission Details

510(k) Number K841264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1984
Decision Date June 15, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K841264.
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · Baxter Healthcare Corp · Apr 1988
CIRCUIT ANES. BREATHING & COMPONENTS
K862003 · Vital Signs, Inc. · Jul 1986
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · Vital Signs, Inc. · May 1986
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · Airlife, Inc. · Nov 1983
SPIROMETER ISOLATION VALVE #8890
K833088 · Boehringer Mannheim Corp. · Oct 1983
POSITIVE CLOSURE ANESTHETIC VALVE
K811015 · Orthopedic Systems, Inc. · May 1981