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Superjet Disposable Blood Lancet

by Medrobe Laboratories

510(k) K833812

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833812 Date12 Dec 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMK
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Superjet Disposable Blood Lancet is a single-use blood lancet classified under FDA Product Code FMK. It is designed as a disposable device featuring a single-use blade attached to a solid, non-reusable base, intended for puncturing the skin to obtain a drop of blood for diagnostic purposes.

This device is supplied sterile and intended for one-time use only. It is regulated under FDA 510(k) clearance (K833812) and falls under the General, Plastic Surgery advisory committee category. The lancet is not reusable and does not require special storage conditions beyond standard sterile device handling.

Other devices from Medprobe Laboratories

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Superjet Disposable Blood Lancet intended for?

    The Superjet Disposable Blood Lancet is intended for puncturing the skin to obtain a drop of blood for diagnostic purposes, as stated in its description. It is a single-use device designed for this specific function and is not intended for any other clinical use.

  • Is the Superjet Disposable Blood Lancet reusable or single-use?

    The Superjet Disposable Blood Lancet is intended for one-time use only and is not reusable. It features a single-use blade attached to a solid, non-reusable base, and the device description explicitly states it is supplied sterile and intended for single-use only.

  • How is the Superjet Disposable Blood Lancet supplied in terms of sterility?

    The Superjet Disposable Blood Lancet is supplied sterile, as indicated in the device description. It is designed to be used directly from its packaging without additional sterilization, maintaining sterility until point of use under standard handling conditions.

  • What regulatory pathway was used for the Superjet Disposable Blood Lancet?

    The Superjet Disposable Blood Lancet was cleared through the FDA 510(k) pathway, specifically under traditional clearance with K833812, as noted in the AUTHORIZATIONS and SPECIFICATIONS sections. It was found substantially equivalent to a predicate device.

  • Does the Superjet Disposable Blood Lancet require special storage conditions?

    The Superjet Disposable Blood Lancet does not require special storage conditions beyond standard sterile device handling. The description states it is supplied sterile and intended for one-time use only, with no mention of temperature, humidity, or other special storage needs.