Cleared Traditional

K915833 - SENSORMEDICS MODEL 2600 PEDIATRIC PULMO...

K915833 is an FDA 510(k) clearance for SENSORMEDICS MODEL 2600 PEDIATRIC PULMO..., manufactured by Sensor Medics Corp.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K915833 · Sensor Medics Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Dec 1992
Decision
344d
Days
Class 2
Risk

K915833 is an FDA 510(k) clearance for the SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on December 2, 1992 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sensor Medics Corp. devices

FDA 510(k) Submission Details - K915833

510(k) Number K915833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date December 02, 1992
Days to Decision 344 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 140d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 24
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K915833.
CO 2 SMO PLUS
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MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · Sensor Medics Corp. · Dec 1992
Q-PLEX 1
K881235 · Quinton, Inc. · Mar 1989
ALVEO-DIFFUSION TEST
K853443 · Erich Jaeger, Inc. · Feb 1986