510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K214022Substantially Equivalent

Accu-Chek Softclix Blood Lancing System

Roche Diabetes Care, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K214022 is the FDA 510(k) clearance record for Accu-Chek Softclix Blood Lancing System, a class II device, cleared for Roche Diabetes Care, Inc. on under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only). FDA's definition for product code QRL reads: "A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes". FDA records list 13 510(k) clearances for Roche Diabetes Care, Inc., from to . As of , FDA records show no recalls naming K214022.

Clearance record

Decision date
Received
(57 days to decision)
Product code
QRL Multiple Use Blood Lancet For Single Patient Use Only
Regulation
21 CFR 878.4850
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Roche Diabetes Care, Inc. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRL

Trailing 12 months
4 clearances under product code QRL in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QRL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20261
September 20260
October 20260