510(k) · Cleared
ClearedInTray GC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomed Diagnostics Incorporated · JTY Culture Media, For Isolation Of Pathogenic Neisseria
Cleared on Oct 20, 2021 as substantially equivalent to K993033 (Biomed Diagnostics, Inc., 1999) after a 239-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Oct 20, 2021
- Review
- 239 days
- Class
- Class II
- Product code
- JTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993033 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993033 Intray GCBiomed Diagnostics, Inc. · 1999
- This deviceK210511 InTray GCBiomed Diagnostics Incorporated · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993033 | Intray GC | Biomed Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K210511 | InTray GC | Biomed Diagnostics Incorporated | 2021 | — |
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 JTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K993033 | Intray GCSummary page 4…sseria Spp Classification name: Culture medium for pathogenic Neisseria spp Class II, 21 CFR 866.2410, (Device product code: JTY). Predicate device InTray GC, 510K# K993033 cleared in 1999 Device description The InTray GC is a Modified Thayer-Martin medium within a sealed inner well.… | 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.
How does its category compare?
All JTY devicesJTY Culture Media, For Isolation Of Pathogenic Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JTY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JTY
Too few JTY 510(k)s in any year since 2007 to give a median.
Recalls per year · JTY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTY
35in 2025
MAUDE reports naming product code JTY, 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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae when incubated at 35°C for 24-72 hours. Inoculated samples can optionally be pre-incubated prior to transport when pre-incubated at 35°C for 24 hours. Subsequent transport, of the pre-incubated specimen under controlled room temperature (18 to 25°C), is supported out to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210511: InTray GC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210511
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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