510(k) · Cleared
ClearedNipro Transducer Protector TP-Sure, Model Tpsure+1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · FIB Protector, Transducer, Dialysis
Cleared on Feb 21, 2008 as substantially equivalent to K983076 (Medisystems Corp., 1998) and 1 other predicate after a 121-day review. Its family tree reaches back 2 generations to 1982. 1 later device descends from it.
- Decided
- Feb 21, 2008
- Review
- 121 days
- Class
- Class II
- Product code
- FIB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K820459 (1982). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK820459 Viragard/VirashieldTri-Med, Inc. · 1982
- 1 generation backK983076 Medisystems Transducer ProtectorMedisystems Corp. · 1998
- This deviceK072988 Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008
- Descendant · cites it directly · 0 of its ownK240164 NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820459 | Viragard/Virashield | Tri-Med, Inc. | 1982 | — |
| −1 | K983076 | Medisystems Transducer Protector | Medisystems Corp. | 1998 | — |
| 0 (this device) | K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1 | Nipro Medical Corporation | 2008 | — |
| +1 | K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 FIB? 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 FIB device
- #1 K240164 NovaLine SP-C35 Transducer Protector (956007)score 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K983076 | Medisystems Transducer ProtectorSummary page 1…n Number: 21 CFR 876,5820 Panel: 78 Product Code: FIB 807.92(a) (3) Legally marketed substantial equivalent device: K983076 - Medisystems Transducer Protectors K072024 - NIPRO Set - Blood Tubing Set with transducer protectors and… | 1998 |
| * | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219…Summary page 1…Product Code: FIB 807.92(a) (3) Legally marketed substantial equivalent device: K983076 - Medisystems Transducer Protectors K072024 - NIPRO Set - Blood Tubing Set with transducer protectors and priming set. 807.92(a) (4) Descrip… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | 2024 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K240164 (Bain Medical Equipment (Guangzhou) Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FIB devicesFIB Protector, Transducer, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FIB
Too few FIB 510(k)s in any year since 2007 to give a median.
Recalls per year · FIB
No recall names FIB since 2007.
Adverse event reports per year · FIB
2in 2017
MAUDE reports naming product code FIB, 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 | 1 | — | 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 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072988 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072988: Nipro Transducer Protector TP-Sure, Model Tpsure+1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072988
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