Product code JTO: 510(k) clearances and predicates
Product code JTO covers IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT. FDA lists 244 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
244 clearances on file under product code JTO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JTO clearances in the FDA index, with applicant and decision date:
- K050352, IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT, applicant Ameritek Research, LLC, decided 2005-09-01. FDA record
- K970832, PYR SWAB, applicant Remel, Inc., decided 1997-04-24. FDA record
- K970834, GRAM SWAB, applicant Remel, Inc., decided 1997-04-17. FDA record
- K970833, INDOLE SWAB, applicant Remel, Inc., decided 1997-04-02. FDA record
- K970009, LYFO(TM) DIFFERENTIAL DISK-BACITRACIN, applicant Microbiologics, Inc., decided 1997-02-06. FDA record
- K962966, IDS RAPID CB PLUS SYSTEM, applicant Innovative Diagnostic Systems, Inc., decided 1996-10-08. FDA record
- K961191, COLISCREEN, applicant Hardy Diagnostics, decided 1996-06-17. FDA record
- K960996, M. CAT BUTYRATE DISK, applicant Hardy Diagnostics, decided 1996-04-18. 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 PYR SWAB, GRAM SWAB. Watch new JTO 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 JTO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JTO clearances include IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT.
How many 510(k) clearances use product code JTO?
244 at the time this page was generated, from openFDA records.
How do I find a predicate device under JTO?
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 JTO clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.