510(k) · Cleared
ClearedFasttake Adapter, Model # P/N 020-072-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selfcare, Inc. · JQP Calculator/Data Processing Module, For Clinical Use
Cleared on Dec 17, 1998 as substantially equivalent to K952279 (Medisense, Inc., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 17, 1998
- Review
- 77 days
- Class
- Class I
- Product code
- JQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952279 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- This deviceK983468 Fasttake Adapter, Model # P/N 020-072-01Selfcare, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| 0 (this device) | K983468 | Fasttake Adapter, Model # P/N 020-072-01 | Selfcare, Inc. | 1998 | — |
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 JQP? 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 |
|---|---|---|---|
| * | K952279 | Precision Link Blood Glucose Data Management SystemSummary page 1…ent of the Precision Link™ Blood Glucose Data Management System. The predicate device is manufactured by Medisense, Inc and was “cleared for use in the United States by K952279. The Precision Link™ System, which is classified as a data management system, is comprised of five separate components: data mana… | 1995 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K952279.
How does its category compare?
All JQP devicesJQP Calculator/Data Processing Module, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JQP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JQP
Too few JQP 510(k)s in any year since 2007 to give a median.
Recalls per year · JQP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JQP
113in 2025
MAUDE reports naming product code JQP, 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 | — | 3 | 22 |
| 2008 | 0 | — | 6 | 9 |
| 2009 | 0 | — | 9 | 14 |
| 2010 | 0 | — | 7 | 45 |
| 2011 | 0 | — | 9 | 128 |
| 2012 | 1 | — | 6 | 102 |
| 2013 | 0 | — | 5 | 46 |
| 2014 | 0 | — | 3 | 85 |
| 2015 | 0 | — | 10 | 142 |
| 2016 | 0 | — | 12 | 204 |
| 2017 | 0 | — | 2 | 110 |
| 2018 | 0 | — | 10 | 218 |
| 2019 | 0 | — | 2 | 253 |
| 2020 | 0 | — | 2 | 52 |
| 2021 | 0 | — | 0 | 105 |
| 2022 | 0 | — | 3 | 166 |
| 2023 | 0 | — | 0 | 171 |
| 2024 | 0 | — | 5 | 102 |
| 2025 | 0 | — | 1 | 113 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Lifescan FastZake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the Fast7 ake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake® Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.
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/K983468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983468: Fasttake Adapter, Model # P/N 020-072-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983468
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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