Product code JAK: 510(k) clearances and predicates
Product code JAK covers BodyTom 64 (NL4100); OmniTom Elite (NL5000). FDA lists 825 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
825 clearances on file under product code JAK. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 30 |
| 2023 | 27 |
| 2024 | 26 |
| 2025 | 27 |
| 2026 so far | 19 |
Recent clearances
Newest JAK clearances in the FDA index, with applicant and decision date:
- K261125, BodyTom 64 (NL4100); OmniTom Elite (NL5000), applicant Samsung HME America, Inc., dba NeuroLogica Corp., decided 2026-09-22. FDA record
- K261229, SCENARIA View Phase 6.0, applicant Fujifilm Corporation, decided 2026-09-18. FDA record
- K253836, FCT iStream Phase 2, applicant Fujifilm Corporation, decided 2026-09-04. FDA record
- K253450, BodyTom Elite (NL4000), applicant NeuroLogica Corp., a Samsung Company, decided 2026-07-28. FDA record
- K253770, CardIQ Suite, applicant GE Medical Systems SCS, decided 2026-07-21. FDA record
- K253560, Enhanced Boundary for PCCT, applicant Ge Medical Systems, LLC, decided 2026-06-24. FDA record
- K253026, Respiratory Gating for Scanners (2.1), applicant Varian Medical Systems, Inc., decided 2026-06-04. FDA record
- K253596, Aquilion ONE (TSX-308A/TSX-306A) V2.0, applicant Canon Medical Systems Corporation, decided 2026-05-20. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SCENARIA View Phase 6.0, FCT iStream Phase 2. Watch new JAK clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JAK?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JAK clearances include BodyTom 64 (NL4100); OmniTom Elite (NL5000).
How many 510(k) clearances use product code JAK?
825 at the time this page was generated, from openFDA records.
How do I find a predicate device under JAK?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JAK clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.