510(k) · Cleared
ClearedH&H Emergency Cricothyrotomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H & H Medical Corporation · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jul 3, 2014 as substantially equivalent to K010016 (Cook, Inc., 2001) after a 230-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 3, 2014
- Review
- 230 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010016 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010016 Melker Cuffed Emergency Cricothyrotomy CatheterCook, Inc. · 2001 · Recalled
- This deviceK133528 H&H Emergency Cricothyrotomy KitH & H Medical Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010016 | Melker Cuffed Emergency Cricothyrotomy Catheter | Cook, Inc. | 2001 | 1 |
| 0 (this device) | K133528 | H&H Emergency Cricothyrotomy Kit | H & H Medical Corporation | 2014 | — |
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 JOH? 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 JOH device
- #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 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 |
|---|---|---|---|
| * | K010016 | Melker Cuffed Emergency Cricothyrotomy CatheterSummary page 1…Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital. This device is intended for Limited Duration Use (<24 hours). Predicate Device K010016 - Cook Melton Emergency Cricothyrotomy Kit (cuffed) cleared 10/9/2001. Table I - Comparison to Predicate Device… | 2001 |
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 a recall.
- 5 other devices also cite its predicate K010016.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, 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 | 1 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The H & H Emergency Cricothyrotomy (cuffed) Tube is indicated for emergency airway access when conventional endotracheal intubation cannot be performed.
It is intended for adult patients for use in the following environments: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital.
This device is intended for Limited Duration Use (<24 hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133528: H&H Emergency Cricothyrotomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133528
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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