510(k) · Cleared
ClearedTAP Blood Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seventh Sense Biosystems, Inc. · PRJ Capillary Blood Collection Device For Alternative Site Collection
Cleared on Nov 5, 2019 as substantially equivalent to K161521 (Seventh Sense Biosystems, Inc., 2017) after a 273-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Nov 5, 2019
- Review
- 273 days
- Class
- Class II
- Product code
- PRJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945952 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 2 generations backK022130 BD Vacutainer Plus PST II TubeBecton, Dickinson & CO · 2002
- 1 generation backK161521 TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 2017
- This deviceK190225 TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 10 |
| −2 | K022130 | BD Vacutainer Plus PST II Tube | Becton, Dickinson & CO | 2002 | — |
| −1 | K161521 | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | 2017 | — |
| 0 (this device) | K190225 | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | 2019 | — |
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 PRJ? 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 |
|---|---|---|---|
| * | K161521 | TAP Blood Collection DeviceSummary page 4…FR 862.1675 Device Class: II Product Code: PRJ Panel: Clinical Chemistry Predicate Device: TAP Blood Collection® Device (K161521) Device Description: The TAP Blood Collection® Device (herein “TAP Device”) is a single- use, ste… | 2017 |
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 7.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All PRJ devicesPRJ Capillary Blood Collection Device For Alternative Site Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PRJ
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PRJ
Too few PRJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PRJ
No recall names PRJ since 2007.
Adverse event reports per year · PRJ
1in 2023
MAUDE reports naming product code PRJ, 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 | 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TAP Blood Collection® Device is a lithium heparin coated single use device intended to be used to collect capillary blood from the upper arm of adults (21 years of age or older). The TAP Blood Collection® Device is for measurement of HbA1c on blood specimens which can be collected by self-administration of the TAP Device by a layperson or by a healthcare worker in a healthcare setting. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin Alc (HbA1c) using tests intended for monitoring glycemic control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190225 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190225: TAP Blood Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190225
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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