510(k) · Cleared
ClearedIntray GC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomed Diagnostics, Inc. · JTY Culture Media, For Isolation Of Pathogenic Neisseria
Cleared on Dec 16, 1999 after a 98-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Dec 16, 1999
- Review
- 98 days
- Class
- Class II
- Product code
- JTY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993033 Intray GCBiomed Diagnostics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK210511 InTray GCBiomed Diagnostics Incorporated · 2021
Most influential descendants
Showing 1 of 1 · See all- K210511InTray GCBiomed Diagnostics Incorporated · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993033 | Intray GC | Biomed Diagnostics, Inc. | 1999 | — |
| +1 | K210511 | InTray GC | Biomed Diagnostics Incorporated | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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.
Top candidate predicates for a new JTY device
- #1 K210511 InTray GCscore 2.2 · 1 generation · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210511 | InTray GC | 2021 | 0 |
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?
- Of its descendants, K210511 (Biomed Diagnostics Incorporated, 2021) has gone furthest, with 0 descendants of its own.
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.
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?
InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993033: 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/K993033
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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