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Infinity Trident Pod System MS15007

by Draeger Medical Systems, Inc.

Infinity Trident Pod System MS15007 is a medical device (FDA Class II; FDA product code KOI, Stimulator, Nerve, Peripheral, Electric) made by Draeger Medical Systems, Inc., cleared under FDA 510(k) K042003 on 1 Sep 2004 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04049098051149), 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) K042003

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 Number04049098051149 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042003 Date1 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042003 decided 1 Sep 2004 Active
  • FDA GUDID UDI-DI 04049098051149 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042003
  2. Listed FDA GUDID 04049098051149

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Infinity Trident Pod System
Generic name
Block-monitoring peripheral nerve electrical stimulation system
Model / reference
MS15007
Primary DI / UDI-DI
04049098051149
510(k) Number
FDA product code
KOI
GMDN term
Block-monitoring peripheral nerve electrical stimulation system
Device class
Class II
Regulation number
868.2775
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric).

Other devices from Draeger Medical Systems, Inc.

See all devices from Draeger Medical Systems, Inc. →

Properties

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