510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080040Substantially Equivalent

Ortho All-Flex Diaphragm

Johnson & Johnson Produtos Profissionais Ltda., Claremont NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080040 is the FDA 510(k) clearance record for ORTHO ALL-FLEX DIAPHRAGM, a class II device, cleared for Johnson & Johnson Produtos Profissionais Ltda. on under FDA product code HDW (Diaphragm, Contraceptive (And Accessories)). FDA records list one 510(k) clearance for Johnson & Johnson Produtos Profissionais Ltda. As of , FDA records show no recalls naming K080040.

Clearance record

Decision date
Received
(231 days to decision)
Product code
HDW Diaphragm, Contraceptive (And Accessories)
Regulation
21 CFR 884.5350
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Johnson & Johnson Produtos Profissionais Ltda. 220 River Rd., Claremont NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDW

Trailing 12 months

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

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