Cleared Traditional

K901399 - POWERBASE II (PB2)

K901399 is the FDA 510(k) clearance for POWERBASE II (PB2) by Nellcor, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901399 · Nellcor, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
78d
Days
Class 2
Risk

K901399 is an FDA 510(k) clearance for the POWERBASE II (PB2). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor, Inc. (Hayward, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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.

View all Nellcor, Inc. devices

Submission Details

510(k) Number K901399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 12, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K901399.
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · Cobe Laboratories, Inc. · Aug 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, Inc. · Feb 1989
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · Baxter Healthcare Corp · Dec 1988