Cleared Traditional

K982776 - 9303 NEONATAL/ADULT VITAL SIGNS MONITOR

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

K982776 · Cas Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 368
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K982776.
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · Siemens Medical Solutions USA, Inc. · May 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
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998
NPB-295 PULSE OXIMETER
K973147 · Nellcor Puritan Bennett, Inc. · Nov 1997
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · Respironics, Inc. · Oct 1997