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Alatus ALA-45 Unit Tray

by Radiadyne, L.L.C.

Alatus ALA-45 Unit Tray is a vaginal speculum (FDA Class II) made by Radiadyne, L.L.C., cleared under FDA 510(k) K092534 on 7 Dec 2009 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00851546007004), 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) K092534

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 Number00851546007004 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092534 Date7 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092534 decided 7 Dec 2009 Active
  • FDA GUDID UDI-DI 00851546007004 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092534
  2. Listed FDA GUDID 00851546007004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alatus
Generic name
Vaginal speculum, single-use
Model / Ref / Catalog
ALA-45 Unit Tray, ALA-45
Primary DI / UDI-DI
00851546007004
510(k) Number
FDA product code
IYE, JAQ
GMDN term
Vaginal speculum, single-use
Device class
Class II
Regulation number
892.5050, 892.5700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Vaginal speculum, single-use

Cleared under the same submission (K092534)

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Radiadyne, L.L.C.

See all devices from Radiadyne, L.L.C. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)