510(k) · Cleared
ClearedCCBIO ASCPO Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cc Biotechnology Corporation · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 13, 2022 as substantially equivalent to K100209 (Becton, Dickinson & CO, 2010) after a 357-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 13, 2022
- Review
- 357 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010188 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK010188 BD Eclipse Hypodermic NeedleBd Medical Systems · 2001
- 2 generations backK043397 Modification to BD Eclipse Hypodermic NeedleBecton, Dickinson & CO · 2004
- 1 generation backK100209 BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO · 2010
- This deviceK214004 CCBIO ASCPO NeedleCc Biotechnology Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010188 | BD Eclipse Hypodermic Needle | Bd Medical Systems | 2001 | — |
| −2 | K043397 | Modification to BD Eclipse Hypodermic Needle | Becton, Dickinson & CO | 2004 | — |
| −1 | K100209 | BD Eclipse Needle with Smartslip Technology | Becton, Dickinson & CO | 2010 | — |
| 0 (this device) | K214004 | CCBIO ASCPO Needle | Cc Biotechnology Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K100209 | BD Eclipse Needle with Smartslip TechnologySummary page 4…eedle and locked immediately after use to minimize risk of accidental needlestick. 5. Information of the 510(k) Cleared Device (Predicate Device): ® BD Eclipse™ Needle (K100209). The reason for choosing BD Eclipse™ Needle (K100209) as the SE predicate model is because that the new ASCPO Needle and BD Ecl… | 2010 |
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 21 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K214004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214004: CCBIO ASCPO Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214004
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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