510(k) · Cleared
ClearedBurron Vented Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Patent Development Corp. · GAA Needle, Aspiration And Injection, Disposable
Cleared on Mar 26, 1979 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Mar 26, 1979
- Review
- 21 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK790472 Burron Vented NeedleNational Patent Development Corp. · 1979
- Descendant · cites it directly · 12 of its ownK013087 Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 2001
- Descendant · 2 generations on · 5 of its ownK040634 Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK071307 Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501…Inviro Medical Devices, Inc. · 2008
- Descendant · 3 generations on · 2 of its ownK072759 VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK140730 VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd. · 2014 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K013087Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 2001 · cites it directly12descendants
- K040634Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp. · 2004 · 2 generations on5descendants
- K071307Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003Inviro Medical Devices, Inc. · 2008 · 2 generations on2descendants
- K072759VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · 3 generations on2descendants
- K140730VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd. · 2014 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K790472 | Burron Vented Needle | National Patent Development Corp. | 1979 | — |
| +1 | K013087 | Single Dose Dispensing Pin, Model 2201 | Alaris Medical Systems, Inc. | 2001 | — |
| +2 | K040634 | Robertsite Vial Adapter, Model 245700021 | Halkey-Roberts Corp. | 2004 | — |
| +2 | K071307 | Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001… | Inviro Medical Devices, Inc. | 2008 | — |
| +3 | K072759 | VIAL2BAG | Medimop Medical Projects, Ltd. | 2007 | Class I |
| +4 | K140730 | VIAL2BAG Direct Connect | Medimop Medical Projects, Ltd. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 1 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 GAA device
- #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013087 | Single Dose Dispensing Pin, Model 2201 | 2001 | 12 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K013087 (Alaris Medical Systems, Inc., 2001) has gone furthest, with 12 descendants of its own.
How does its category compare?
All GAA devicesGAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAA
Too few GAA 510(k)s in any year since 2007 to give a median.
Recalls per year · GAA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAA
348in 2025
MAUDE reports naming product code GAA, 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 | 12 |
| 2008 | 0 | — | 1 | 32 |
| 2009 | 0 | — | 2 | 20 |
| 2010 | 0 | — | 2 | 18 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 122 |
| 2019 | 0 | — | 10 | 153 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 0 | — | 5 | 108 |
| 2022 | 0 | — | 2 | 74 |
| 2023 | 1 | — | 0 | 118 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 0 | — | 0 | 348 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K790472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K790472: Burron Vented Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790472
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026