510(k) · Cleared
ClearedFAST1 Intraosseous Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pyng Medical Corp. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 13, 2008 as substantially equivalent to K970380 (Pyng Medical Corp., 1997) after a 162-day review. Its family tree reaches back 2 generations to 1988. 4 later devices descend from it.
- Decided
- Feb 13, 2008
- Review
- 162 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883014 (1988). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK883014 Modified Intended Use of Monoject Bone Marrow NeedSherwood Medical Co. · 1988
- 1 generation backK970380 F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp. · 1997
- This deviceK072487 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- Descendant · cites it directly · 3 of its ownK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- Descendant · 2 generations on · 2 of its ownK100124 Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK130487 Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK180588 FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal…Teleflex Medical · 2018
Most influential descendants
Showing 4 of 4 · See all- K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · cites it directly3descendants
- K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · 2 generations on2descendants
- K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013 · 2 generations on1descendant
- K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883014 | Modified Intended Use of Monoject Bone Marrow Need | Sherwood Medical Co. | 1988 | — |
| −1 | K970380 | F.a.S.T. 1 Intraosseous Infusion System | Pyng Medical Corp. | 1997 | — |
| 0 (this device) | K072487 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| +1 | K080865 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| +2 | K100124 | Fastx Sternal Intraosseous Device | Pyng Medical Corp. | 2010 | 1 |
| +2 | K130487 | Fastresponder Sternal Intraosseous Device | Pyng Medical Corp. | 2013 | — |
| +2 | 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 |
|---|---|---|
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K970380 | F.a.S.T. 1 Intraosseous Infusion SystemSummary page 1…valence to the modified FAST1 TM Intraosseous Infusion System is based is: FASTI TM Intraosseous Infusion System The 510(k) number for this product is K970380. Indications for Use: The FAST"T M Intraosseous Infusion System is indicated for use in establishing a sternal intraos… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080865 | FAST1 Intraosseous Infusion System | 2008 | 3 |
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 20 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080865 (Pyng Medical Corp., 2008) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K970380.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072487: FAST1 Intraosseous Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072487
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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