Cleared Traditional

K030379 - APLAB, MODEL 801D0030

K030379 is an FDA 510(k) clearance for APLAB, manufactured by Sector Medical Corp.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K030379 · Sector Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
205d
Days
Class 2
Risk

K030379 is an FDA 510(k) clearance for the APLAB, MODEL 801D0030. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Sector Medical Corp. (Acworth, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 205 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K030379

510(k) Number K030379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2003
Decision Date August 29, 2003
Days to Decision 205 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
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - MNR Ventilatory Effort Recorder

All 164
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K030379.
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
K040069 · Dymedix, Inc. · May 2004
COMPUMEDICS SUMMIT IP
K040194 · Compumedics USA, Ltd. · Apr 2004
EMBLA N7000
K024322 · Medcare Flaga · Oct 2003
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
K022506 · Widemed, Ltd. · May 2003
APNEACHECK
K022294 · Im Systems · Apr 2003
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
K030611 · Nellcor Puritan Bennett (Melville) , Ltd. · Mar 2003
K030379 · APLAB, MODEL 801D0030
Download PDF FDA Summary Sector Medical Corp.