Cleared Traditional

K881185 - ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.

K881185 is an FDA 510(k) clearance for ANNULAR ARRAY PROBES FOR ARTIS 3200 DIA..., manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEM cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K881185 · Philips Medical Systems (Cleveland), Inc. · Obstetrics & Gynecology device
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Jun 1988
Decision
72d
Days
Class 2
Risk

K881185 is an FDA 510(k) clearance for the ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.. Classified as Imager, Ultrasonic Obstetric-gynecologic (product code HEM), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2225 - the FDA obstetrics and gynecology 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K881185

510(k) Number K881185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date June 01, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEM Device Classification - Class 2, Special Controls

Product Code HEM Imager, Ultrasonic Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2225
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEM Imager, Ultrasonic Obstetric-gynecologic

All 17
Devices cleared under the same product code (HEM) and FDA review panel - the closest regulatory comparables to K881185.
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