Cleared Traditional

K884072 - 15 MILLIMETER MALE AND FEMALE ADAPTERS

K884072 is the FDA 510(k) clearance for 15 MILLIMETER MALE AND FEMALE ADAPTERS by Eastmed Enterprises, Inc.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K884072 · Eastmed Enterprises, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
10d
Days
Class 1
Risk

K884072 is an FDA 510(k) clearance for the 15 MILLIMETER MALE AND FEMALE ADAPTERS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on October 7, 1988 after a review of 10 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 Eastmed Enterprises, Inc. devices

Submission Details

510(k) Number K884072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1988
Decision Date October 07, 1988
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 K884072.
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · Vital Signs, Inc. · Jul 1991
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · Baxter Healthcare Corp · Jan 1990
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
K893919 · Baxter Healthcare Corp · Sep 1989
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