Cleared Traditional

K990045 - BERACLAMP, MODEL BC-1

K990045 is an FDA 510(k) clearance for BERACLAMP, manufactured by Poamax LLC. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K990045 · Poamax LLC · Obstetrics & Gynecology device
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May 1999
Decision
138d
Days
Class 2
Risk

K990045 is an FDA 510(k) clearance for the BERACLAMP, MODEL BC-1. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Poamax LLC (Poguoson, US). The FDA issued a Cleared decision on May 24, 1999 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Poamax LLC devices

FDA 510(k) Submission Details - K990045

510(k) Number K990045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1999
Decision Date May 24, 1999
Days to Decision 138 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 160d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNA Device Classification - Class 2, Special Controls

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 38
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K990045.
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GYNEX ENDOSPECULUM
K980237 · Gynex Corp. · Apr 1998