510(k) · Cleared
ClearedFAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 17, 2018 as substantially equivalent to K080865 (Pyng Medical Corp., 2008) and 1 other predicate after a 42-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Apr 17, 2018
- Review
- 42 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K915409 (1992). 13 ancestors in all, the oldest K883014 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 6 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 5 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 4 generations backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- 3 generations backK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- 2 generations backK100124 Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · Recalled
- 1 generation backK130487 Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013
- This deviceK180588 FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal…Teleflex Medical · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −6 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −5 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −4 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| −3 | K080865 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| −2 | K100124 | Fastx Sternal Intraosseous Device | Pyng Medical Corp. | 2010 | 1 |
| −1 | K130487 | Fastresponder Sternal Intraosseous Device | Pyng Medical Corp. | 2013 | — |
| 0 (this device) | K180588 | FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device | Teleflex Medical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K080865 | FAST1 Intraosseous Infusion SystemSummary page 4…Class II Review Panel: General Hospital III. PREDICATE DEVICES FAST1™ Intraosseous Infusion System cleared in submission K080865 Classification Name: Needle, Hypodermic, Single Lumen Product Code: FMI Regulation N… | 2008 |
| * | K130487 | Fastresponder Sternal Intraosseous DeviceSummary page 4…Classification: Class II Review Panel: General Hospital FASTResponder™ Sternal Intraosseous Device cleared in submission K130487 Classification Name: Needle, Hypodermic, Single Lumen Product Code: FMI Regulation Num… | 2013 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 2 other devices also cite its predicate K080865.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
The FASTResponder™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluid to facilitate emergency resuscitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180588: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180588
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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