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510(k) K894474

THE AUTOLET LITE by Ulster Scientific, Inc. — Product Code FMK

K894474 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "THE AUTOLET LITE". The FDA issued a decision of Substantially Equivalent on August 18, 1989. The device falls under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1989
Date Received
July 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Other clearances by Ulster Scientific, Inc.

  • K942620 — FEATHER-TOUCH SINGLE-STICK DEVICE (June 22, 1994)
  • K920562 — UNISTIK (March 27, 1992)
  • K902592 — EPC ELECTRONIC PIPETTING SYSTEM (July 19, 1990)
  • K895890 — AUTOPEN (February 16, 1990)
  • K885340 — AIR DISPLACEMENT PIPETTE (February 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K871076 — WINPETTE (March 23, 1987)
  • K870078 — ACCUPEN(R) (March 17, 1987)
  • K864761 — USI AUTOJECT INSULIN SYRINGE (December 16, 1986)

Other clearances for product code FMK

  • K261045 — Verifine Safety Lancets (May 1, 2026)
  • K260191 — Safety lancet (XXXVII) (March 31, 2026)
  • K253605 — Safety Heel Lancet (February 20, 2026)
  • K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (February 12, 2026)
  • K251694 — safety lancet (June 26, 2025)
  • K244036 — Heel Incision Safety Lancet (SteriHeel 2) (February 26, 2025)
  • K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (January 13, 2025)
  • K242680 — LetsGetChecked Impress (January 13, 2025)
  • K242664 — gentleheel® Adult Incision Device (November 5, 2024)
  • K242627 — Safety Lancet (October 30, 2024)

FDA data resources