LANCET, BLOOD— 510(k) K883420

Name: FDA 510(k) clearance K883420
Creator: U.S. Food and Drug Administration
Published: 1988-08-26

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K883420 for LANCET, BLOOD, Substantially Equivalent on 1988-08-26. Applicant: Primrose Medical, Inc.. Device class: 2.

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 1988-08-15
Decision date: 1988-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMK

view all

K262526 — Safety lancet (XL)2026-09-13
K261045 — Verifine Safety Lancets2026-05-01
K260191 — Safety lancet (XXXVII)2026-03-31
K253605 — Safety Heel Lancet2026-02-20
K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12

More clearances from Primrose Medical, Inc.

view all

K884711 — URETHRAL AND URETERAL BALLOON DILATATORS1989-09-29
K884713 — COLONIC BALLOON DIALATORS1989-09-29
K884714 — BILIARY DIALATOR1989-09-29
K884715 — ACHELASIA BALLOON DIALATOR1989-09-29
K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)1989-09-08

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.