510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101892Substantially Equivalent

Heine Gamma G7; Heine Gamma G5, Heine Gamma Gp, Heine Gamma Gst, Heine Gamma Xxl Lf Model M-000.09.23X, M-000.09.24X, M-

Heine Optotechnik GmbH & Co. KG., Hamburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101892 is the FDA 510(k) clearance record for HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-, a class II device, cleared for Heine Optotechnik GmbH & Co. KG on under FDA product code DXQ (Blood Pressure Cuff). FDA's definition for product code DXQ reads: "A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure". FDA records list 7 510(k) clearances for Heine Optotechnik GmbH & Co. KG, from to . As of , FDA records show no recalls naming K101892.

Clearance record

Decision date
Received
(51 days to decision)
Product code
DXQ Blood Pressure Cuff
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Applicant
Heine Optotechnik GmbH & Co. KG Beim Strohhause 27, Hamburg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXQ

Trailing 12 months
5 clearances under product code DXQ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260