510(k) · Cleared
Clearedhypodermic Pinpoint™ GT Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · PVZ Non-Stainless Steel Needle
Cleared on Jun 23, 2017 as substantially equivalent to K021475 (Bd, 2002) after a 198-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jun 23, 2017
- Review
- 198 days
- Class
- Class II
- Product code
- PVZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931367 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −1 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| 0 (this device) | K163437 | hypodermic Pinpoint™ GT Needle | C.R. Bard, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 PVZ? 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? (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 |
|---|---|---|---|
| * | K021475 | BD Single Lumen Needle, Syringe and Blood Collection SetSummary page 4…VZ Manufacturer: Bard Access Systems, Inc. Classification Panel: General Hospital Premarket Notification: K021475; date of clearance, July 19, 2002 Trade Name: BD Single Lumen Needle Common Name:… | 2002 |
| † | K142445 | Pinpoint GT Safety Introducer Needle | 2015 |
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 24 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 6 other devices also cite its predicate K021475.
How does its category compare?
All PVZ devicesPVZ Non-Stainless Steel Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PVZ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PVZ
Too few PVZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PVZ
No recall names PVZ since 2007.
Adverse event reports per year · PVZ
No MAUDE report names PVZ 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The hypodermic Pinpoint™ GT Needle is intended for the injection of medication into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection/aspiration. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163437: hypodermic Pinpoint™ GT Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163437
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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