510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K831998Substantially Equivalent

Birthwell Birthing System

Qulab Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831998 is the FDA 510(k) clearance record for BIRTHWELL BIRTHING SYSTEM, a class II device, cleared for Qulab Co. on under FDA product code KNC (Table, Obstetric (And Accessories)). FDA records list one 510(k) clearance for Qulab Co. As of , FDA records show no recalls naming K831998.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KNC Table, Obstetric (And Accessories)
Regulation
21 CFR 884.4900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Qulab Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KNC

Trailing 12 months

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

FDA records show no clearances under product code KNC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNC, 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