510(k) · Cleared
ClearedRusch Easycric Emergency Cricothyrotomy Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · BWC Needle, Emergency Airway
Cleared on Nov 6, 2013 as substantially equivalent to K013916 (Cook, Inc., 2001) after a 260-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 6, 2013
- Review
- 260 days
- Class
- Class II
- Product code
- BWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010016 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 BWC? 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 BWC device
- #1 K200190 ScalpelCricscore 0.6 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K013916 | Melker Emergency Cricothyrotomy Catheter SetSummary page 2…ate device: Features Proposed Predicate K013916 Device Rusch EasyCric Emergency Melker Emergency Cricothyrotomy Cricothyrotomy S… | 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K013916.
How does its category compare?
All BWC devicesBWC Needle, Emergency Airway: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · BWC
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · BWC
Too few BWC 510(k)s in any year since 2007 to give a median.
Recalls per year · BWC
1in 2019
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BWC
1in 2024
MAUDE reports naming product code BWC, 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 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 1 (1) | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130405: Rusch Easycric Emergency Cricothyrotomy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130405
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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