510(k) · Cleared
ClearedInfinity Trident NMT Pod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · KOI Stimulator, Nerve, Peripheral, Electric
Cleared on Sep 1, 2004 as substantially equivalent to K992598 (Organon Teknika Corp., 1999) after a 37-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Sep 1, 2004
- Review
- 37 days
- Class
- Class II
- Product code
- KOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992598 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992598 Tof-Watch SXOrganon Teknika Corp. · 1999
- This deviceK042003 Infinity Trident NMT PodDraeger Medical Systems, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992598 | Tof-Watch SX | Organon Teknika Corp. | 1999 | — |
| 0 (this device) | K042003 | Infinity Trident NMT Pod | Draeger Medical Systems, Inc. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOI device
- #1 K261098 TetraGraph Neuromuscular Transmission Monitor…score 21.1 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992598 | Tof-Watch SXSummary page 1…, e eaEeti KOI HI 868.2775 3. Predicate Device Identification: Organon Teknika Corp. Tof-Watch Sx K(992598 4. Device Description: The Infinity Trident NMT Pod is an addition to Draeger Medical Systems' Infinity patient… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K992598.
How does its category compare?
All KOI devicesKOI Stimulator, Nerve, Peripheral, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOI
174in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOI
No recall names KOI since 2007.
Adverse event reports per year · KOI
5in 2025
MAUDE reports naming product code KOI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 3 | 174 | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Infinity Trident NMT pod can be used as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042003: Infinity Trident NMT Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042003
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026