Skip to content

ML7040 (Plano) ML7040 (0)

by Med Logics Inc

ML7040 (Plano) ML7040 (0) is a keratome blade (FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Med Logics Inc, cleared under FDA 510(k) K002515 on 22 Feb 2001 and listed in FDA GUDID since 14 Aug 2020 (UDI-DI 00850724001148), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K002515

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850724001148 UDI-DI Date14 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002515 Date22 Feb 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002515 decided 22 Feb 2001 Active
  • FDA GUDID UDI-DI 00850724001148 listed 14 Aug 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K002515
  2. Listed FDA GUDID 00850724001148

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ML7040 (Plano)
Generic name
Keratome blade, single-use
Model / Ref / Catalog
ML7040 (0)
Primary DI / UDI-DI
00850724001148
510(k) Number
FDA product code
HNO
GMDN term
Keratome blade, single-use
Device class
Class I
Regulation number
886.4370
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Keratome blade, single-use

Cleared under the same submission (K002515)

Similar devices

Other devices filed under FDA product code HNO (Keratome, Ac-Powered).

Other devices from Med Logics Inc

See all devices from Med Logics Inc →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)