510(k) · Cleared
ClearedInitary Better Bladder-Pediatric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circulatory Technology, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Apr 17, 2014 as substantially equivalent to K981284 (Circulatory Technology, Inc., 1998) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 17, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964337 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964337 Better-Bladder (BB)Circulatory Technology, Inc. · 1997
- This deviceK140321 Initary Better Bladder-PediatricCirculatory Technology, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964337 | Better-Bladder (BB) | Circulatory Technology, Inc. | 1997 | — |
| 0 (this device) | K140321 | Initary Better Bladder-Pediatric | Circulatory Technology, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K981284 | Better-Bladder (BB)Summary page 1…ts, which in turn can be used as input signals to control the pump speed. Equivalent Device: Trade Name: Better-Bladder""" 5 10(k) number: K981284 and K964337 Indication for Use: The better-bladder is a device that isolates pressure transducers from blood co… | 1998 |
| * | K964337 | Better-Bladder (BB)Summary page 1…turn can be used as input signals to control the pump speed. Equivalent Device: Trade Name: Better-Bladder""" 5 10(k) number: K981284 and K964337 Indication for Use: The better-bladder is a device that isolates pressure transducers from blood contact when… | 1997 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Better-BladderN! is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140321: Initary Better Bladder-Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140321
Report an extraction error
Are you the manufacturer?
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