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PRIMUS Sterilizer PSS5-E-M

by Primus Sterilizer Company, LLC.

PRIMUS Sterilizer PSS5-E-M is a Class II device made by Primus Sterilizer Company, LLC., cleared under FDA 510(k) K991575 on 3 Dec 1999 and listed in FDA GUDID since 5 Mar 2019 (UDI-DI 00850005738053), active as of 23 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 23 Oct 2026

Documents

510(k) K991575

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850005738053 UDI-DI Date5 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK991575 Date3 Dec 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991575 decided 3 Dec 1999 Active
  • FDA GUDID UDI-DI 00850005738053 listed 5 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K991575
  2. Listed FDA GUDID 00850005738053

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PRIMUS Sterilizer
Generic name
Steam sterilizer
Model / reference
PSS5-E-M
Primary DI / UDI-DI
00850005738053
510(k) Number
FDA product code
FLE
GMDN term
Steam sterilizer
Device class
Class II
Regulation number
880.6880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Steam sterilizer

Cleared under the same submission (K991575)

and 4 more cleared under K991575

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, Steam).

Other devices from Primus Sterilizer Company, LLC.

See all devices from Primus Sterilizer Company, LLC. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)