510(k) · Cleared
Cleared0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · QTI Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Cleared on Jul 16, 2022 as substantially equivalent to K161552 (Becton, Dickinson and Company, 2017) and 1 other predicate after a 211-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Jul 16, 2022
- Review
- 211 days
- Class
- Class II
- Product code
- QTI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K030467 (2003). 12 ancestors in all, the oldest K833182 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 4 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 3 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 2 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 1 generation backK112791 Sitescrub Ipa DeviceC. R. Bard · 2012
- This deviceK213955 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −4 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −3 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −2 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −1 | K112791 | Sitescrub Ipa Device | C. R. Bard | 2012 | — |
| 0 (this device) | K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Becton, Dickinson and Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 QTI? 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? (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 |
|---|---|---|---|
| * | K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeSummary page 5…ate Device Syringe Page 1 of 11 510(k) Number: K161552 Classification Name: Saline, Vascular Access Flush Regulation Number: 21… | 2017 |
| * | K112791 | Sitescrub Ipa DeviceSummary page 5…Classification Panel: General Hospital Trade Name: SiteScrub IPA Device 510(k) Number: K112791 Classification Name: Pad, Alcohol, Device Disinfectant Predicate Device Regulation Number:… | 2012 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K161552.
How does its category compare?
All QTI devicesQTI Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QTI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QTI
Too few QTI 510(k)s in any year since 2007 to give a median.
Recalls per year · QTI
No recall names QTI since 2007.
Adverse event reports per year · QTI
2in 2025
MAUDE reports naming product code QTI, 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
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/K213955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213955: 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213955
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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