510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861513Substantially Equivalent

La Diffusion Technique, Kty Cm-10 Breast Pump

Crystal Medical Products, Inc., Barrington IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861513 is the FDA 510(k) clearance record for LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP, a class II device, cleared for Crystal Medical Products, Inc. on under FDA product code HGX (Pump, Breast, Powered). FDA records list 5 510(k) clearances for Crystal Medical Products, Inc., from to . As of , FDA records show no recalls naming K861513.

Clearance record

Decision date
Received
(107 days to decision)
Product code
HGX Pump, Breast, Powered
Regulation
21 CFR 884.5160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Crystal Medical Products, Inc. 118 Barrington Commons Plz., Barrington IL
Third party review
No

Clearances, product code HGX

Trailing 12 months
37 clearances under product code HGX in the twelve months to October 2026, April 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code HGX, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20262
April 20268
May 20263
June 20268
July 20262
August 20262
September 20263
October 20260