510(k) · Cleared
ClearedBioport Closed Blood Sampling System, Model BT Xxxxxx- BP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunscope Intl., Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Feb 5, 1999 as substantially equivalent to K885281 (Baxter Healthcare Corp, 1989) after a 134-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Feb 5, 1999
- Review
- 134 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K885281 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989 · Recalled
- This deviceK983372 Bioport Closed Blood Sampling System, Model BT Xxxxxx- BPSunscope Intl., Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885281 | Vamp Venous/Arterial Blood Management Protection | Baxter Healthcare Corp | 1989 | 1 |
| 0 (this device) | K983372 | Bioport Closed Blood Sampling System, Model BT Xxxxxx- BP | Sunscope Intl., Inc. | 1999 | — |
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 DRS? 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 DRS device
- #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.4 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K885281 | Vamp Venous/Arterial Blood Management ProtectionSummary page 2…Device in relation to Predicate Device(s) The configuration of the BIOPORT System with attached Reservoir Syringe is similar to that of the predicate arm-mounted VAMP (K885281). Heparinized, diluted blood is drawn into the VAMP reservoir to clear the BIOPORT and distal volume in the VAMP. It is drawn int… | 1989 |
| * | — | Utah Medical Products Inc.'s ABC Pressure Monitoring Kits Named without a submission number | |
| * | — | Migada Blunt Cannula Named without a submission number |
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 a recall.
- 3 other devices also cite its predicate K885281.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
MAUDE reports naming product code DRS, 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 | 1 | — | 0 | 397 |
| 2008 | 0 | — | 0 | 531 |
| 2009 | 2 | — | 0 | 344 |
| 2010 | 2 | — | 0 | 115 |
| 2011 | 3 | 135 | 0 | 63 |
| 2012 | 1 | — | 0 | 43 |
| 2013 | 1 | — | 0 | 39 |
| 2014 | 1 | — | 0 | 23 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 3 | 186 | 162 | 89 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 0 | — | 11 | 82 |
| 2019 | 0 | — | 0 | 84 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 95 |
| 2023 | 1 | — | 15 | 147 |
| 2024 | 0 | — | 0 | 205 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 1 | — | 2 (2) | — |
What is it indicated for?
The BIOPORT System is designed for closed, needle-free access of arterial biood from pressure monitoring catheters.
The BIQPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - % “). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to pemit needie-free withdrawal of undiluted bicod from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undiluted sample is drawn, the heparnnized, diluted blood in the Reservoir Synnge is reinfused into the patient to reduce fluid loss.
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/K983372 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983372: Bioport Closed Blood Sampling System, Model BT Xxxxxx- BP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983372
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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