510(k) · Cleared
Recalled · 2004Abg Point Lok Needle Protection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Industries, Inc. · CBT Arterial Blood Sampling Kit
Cleared on Nov 20, 1995 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Nov 20, 1995
- Review
- 87 days
- Class
- Class I
- Product code
- CBT
- Recalls
- 3
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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.
Planning a device in CBT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2004 | Not classified | Z-0858-04 | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. |
| Mar 29, 2004 | Not classified | Z-0860-04 | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. |
| Mar 29, 2004 | Not classified | Z-0859-04 | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CBT devicesCBT Arterial Blood Sampling Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBT
2in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · CBT
Too few CBT 510(k)s in any year since 2007 to give a median.
Recalls per year · CBT
14in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBT
20in 2025
MAUDE reports naming product code CBT, 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 | 2 | — | 2 | 5 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 14 | 6 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K954015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954015: Abg Point Lok Needle Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954015
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026