Cleared Traditional

K102835 - VITAL SIGNS MONITOR

K102835 is an FDA 510(k) clearance for VITAL SIGNS MONITOR, manufactured by Edan Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K102835 · Edan Instruments, Inc. · Anesthesiology device
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Dec 2010
Decision
89d
Days
Class 2
Risk

K102835 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on December 27, 2010 after a review of 89 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 Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K102835

510(k) Number K102835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date December 27, 2010
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K102835.
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