510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042003Substantially Equivalent

Infinity Trident Nmt Pod

Draeger Medical Systems, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042003 is the FDA 510(k) clearance record for INFINITY TRIDENT NMT POD, a class II device, cleared for Draeger Medical Systems, Inc. on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 48 510(k) clearances for Draeger Medical Systems, Inc., from to . As of , FDA records show no recalls naming K042003.

Clearance record

Decision date
Received
(37 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Draeger Medical Systems, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KOI

Trailing 12 months
1 clearance under product code KOI in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260