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Codonics SLS500i Operating Software 2.1.2

by Codonics Inc.

Codonics SLS500i Operating Software 2.1.2 is a Class II device made by Codonics Inc., cleared under FDA 510(k) K101439 on 7 Feb 2011 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 00814905020014), 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) K101439

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 Number00814905020014 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101439 Date7 Feb 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101439 decided 7 Feb 2011 Active
  • FDA GUDID UDI-DI 00814905020014 listed 23 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101439
  2. Listed FDA GUDID 00814905020014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Codonics SLS500i Operating Software
Generic name
Parenteral-nutrition management software
Model / reference
2.1.2
Primary DI / UDI-DI
00814905020014
510(k) Number
FDA product code
BSZ
GMDN term
Parenteral-nutrition management software
Device class
Class II
Regulation number
868.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Parenteral-nutrition management software

Cleared under the same submission (K101439)

and 6 more cleared under K101439

Similar devices

Other devices filed under FDA product code BSZ (Gas-Machine, Anesthesia).

Other devices from Codonics Inc.

See all devices from Codonics Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)