Cleared Traditional

K992902 - AMBU HAND POWER SUCTION PUMP

K992902 is an FDA 510(k) clearance for AMBU HAND POWER SUCTION PUMP, manufactured by Ambu, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K992902 · Ambu, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
56d
Days
Class 1
Risk

K992902 is an FDA 510(k) clearance for the AMBU HAND POWER SUCTION PUMP. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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 - K992902

510(k) Number K992902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1999
Decision Date October 25, 1999
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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 - BSY Catheters, Suction, Tracheobronchial

All 56
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K992902.
HI-CARE CLOSED SUCTION SYSTEM
K972258 · Mallinckrodt Medical · Dec 1997
TRACH CARE SET WITH MICROBAN
K964369 · Ballard Medical Products · Feb 1997
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K955831 · Sherwood Medical Co. · Mar 1996
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K951506 · Trinity Laboratories, Inc. · Jul 1995
CONNECTING TUBE
K951745 · Vital Signs, Inc. · May 1995
TRIGUARD(TM) SUCTION SYSTEM
K945950 · Vital Signs, Inc. · Dec 1994