Cleared Traditional

K982776 - 9303 NEONATAL/ADULT VITAL SIGNS MONITOR

K982776 is an FDA 510(k) clearance for 9303 NEONATAL/ADULT VITAL SIGNS MONITOR, manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982776 · Cas Medical Systems, Inc. · Anesthesiology device
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Nov 1998
Decision
88d
Days
Class 2
Risk

K982776 is an FDA 510(k) clearance for the 9303 NEONATAL/ADULT VITAL SIGNS MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on November 2, 1998 after a review of 88 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 Cas Medical Systems, Inc. devices

FDA 510(k) Submission Details - K982776

510(k) Number K982776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date November 02, 1998
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 577
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K982776.
EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
K990082 · Epic Medical Equipment Services, Inc. · Apr 1999
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
K982728 · Nellcor Puritan Bennett, Inc. · Dec 1998
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
K983684 · Datex-Ohmeda, Inc. · Nov 1998
MODEL 2000 PULSE OXIMETER
K982255 · Ivy Biomedical Systems, Inc. · Oct 1998
SPO2 FINGER PROBES
K973970 · Medical Cables, Inc. · Oct 1998
MAGNATEK 40
K982907 · Magna Advanced Technologies, Inc. · Oct 1998