Cleared Traditional

K844149 - AMBU RUBEN CIRCLE ANESTHESIA SYSTEM

K844149 is an FDA 510(k) clearance for AMBU RUBEN CIRCLE ANESTHESIA SYSTEM, manufactured by Ambu, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K844149 · Ambu, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
22d
Days
Class 1
Risk

K844149 is an FDA 510(k) clearance for the AMBU RUBEN CIRCLE ANESTHESIA SYSTEM. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Ambu, Inc. (Danbury, US). The FDA issued a Cleared decision on November 15, 1984 after a review of 22 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 Ambu, Inc. devices

FDA 510(k) Submission Details - K844149

510(k) Number K844149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1984
Decision Date November 15, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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 53
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K844149.
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · Vital Signs, Inc. · May 1986
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
K852632 · Medicomp, Inc. · Jan 1986
HYDRO-BAC FILTER
K852866 · Medicomp, Inc. · Jan 1986
SAMSON 1000 ANESTHESIA CIRCUIT
K842488 · J. H. Emerson Co. · Jul 1984
BABYSET TM & PAC TM -PULMONARY ASSIST
K841264 · Life Design Systems, Inc. · Jun 1984
CIRCUIT BREATHING
K840740 · Marquest Medical Products, Inc. · Apr 1984