510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K990045Substantially Equivalent

Beraclamp, Model Bc-1

Poamax LLC, Poguoson VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990045 is the FDA 510(k) clearance record for BERACLAMP, MODEL BC-1, a class II device, cleared for Poamax LLC on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list one 510(k) clearance for Poamax LLC. As of , FDA records show no recalls naming K990045.

Clearance record

Decision date
Received
(138 days to decision)
Product code
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Poamax LLC 17 Alphus St., Poguoson VA
510(k) summary
Statement
Third party review
No

Clearances, product code KNA

Trailing 12 months

FDA records hold no clearances under product code KNA in the trailing twelve months.

FDA records show no clearances under product code KNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260