510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012230Substantially Equivalent

Phem-Alert

Femtek,Llc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012230 is the FDA 510(k) clearance record for PHEM-ALERT, a class I device, cleared for Femtek,Llc. on under FDA product code LNW (Paper, Obstetric Ph). FDA records list 3 510(k) clearances for Femtek,Llc., from to . As of , FDA records show no recalls naming K012230.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LNW Paper, Obstetric Ph
Regulation
21 CFR 862.1550
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Femtek,Llc. 11605 Hitching Post Ln., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code LNW

Trailing 12 months

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

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