510(k) · Cleared
ClearedBD Bifurcated Needle, Models 301754, 301755, 301756, 301757
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd · SCL Allergen And Vaccine Delivery Needles
Cleared on Mar 20, 2002 as substantially equivalent to K012515 (Precision Medical Products, Inc., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Mar 20, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- SCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012515 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK012515 Bifurcated Vaccinating NeedlePrecision Medical Products, Inc. · 2001
- This deviceK020523 BD Bifurcated Needle, Models 301754, 301755, 301756, 301757Bd · 2002
- Descendant · cites it directly · 0 of its ownK222385 Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012515 | Bifurcated Vaccinating Needle | Precision Medical Products, Inc. | 2001 | — |
| 0 (this device) | K020523 | BD Bifurcated Needle, Models 301754, 301755, 301756, 301757 | Bd | 2002 | — |
| +1 | K222385 | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 SCL? 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 SCL device
- #1 K250983 Medblue Skin Prick Test Applicator (AS103…score 11.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K012515 | Bifurcated Vaccinating NeedleSummary page 5…Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847- 4513 Fax (201) B47- 4855 Device Name: BD Bifurcated Needle 2 Predicate Device(s): 2.1 Precision Medical Products - K012515 2.2 BD Vacutainer® Brand Blood Collection Needle - Pre-Amendment 3 Product Description / Function: Product sizes/reorder number… | 2001 |
| * | — | BD Vacutainer® Brand Blood Collection Needle Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222385 | Bifurcated Needle | 2022 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K222385 (Anhui Tiankang Medical Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SCL devicesSCL Allergen And Vaccine Delivery Needles: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · SCL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · SCL
Too few SCL 510(k)s in any year since 2007 to give a median.
Recalls per year · SCL
No recall names SCL since 2007.
Adverse event reports per year · SCL
No MAUDE report names SCL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
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/K020523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020523: BD Bifurcated Needle, Models 301754, 301755, 301756, 301757.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020523
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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