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Flyte System MTI-1.5

by Pelvital USA, Inc.

Flyte System MTI-1.5 is a Class II device made by Pelvital USA, Inc., cleared under FDA 510(k) K240805 on 1 Aug 2024 and listed in FDA GUDID since 6 Jul 2026 (UDI-DI 00860331002063), 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) K240805

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 Number00860331002063 UDI-DI Date6 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240805 Date1 Aug 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240805 decided 1 Aug 2024 Active
  • FDA GUDID UDI-DI 00860331002063 listed 6 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240805
  2. Listed FDA GUDID 00860331002063

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flyte System
Generic name
Perineometer
Model / reference
MTI-1.5
Primary DI / UDI-DI
00860331002063
510(k) Number
FDA product code
HIR
GMDN term
Perineometer
Device class
Class II
Regulation number
884.1425
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HIR (Perineometer).

Other devices from Pelvital USA, Inc.

See all devices from Pelvital USA, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)