510(k) · Cleared
ClearedNovaLine SP-C35 Transducer Protector (956007)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bain Medical Equipment (Guangzhou) Co., Ltd. · FIB Protector, Transducer, Dialysis
Cleared on Jun 28, 2024 as substantially equivalent to K072988 (Nipro Medical Corporation, 2008) after a 158-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Jun 28, 2024
- Review
- 158 days
- Class
- Class II
- Product code
- FIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K820459 (1982). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK820459 Viragard/VirashieldTri-Med, Inc. · 1982
- 2 generations backK983076 Medisystems Transducer ProtectorMedisystems Corp. · 1998
- 1 generation backK072988 Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008
- This deviceK240164 NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820459 | Viragard/Virashield | Tri-Med, Inc. | 1982 | — |
| −2 | K983076 | Medisystems Transducer Protector | Medisystems Corp. | 1998 | — |
| −1 | K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1 | Nipro Medical Corporation | 2008 | — |
| 0 (this device) | 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 |
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.
- 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 |
|---|---|---|---|
| * | K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1Summary page 7…ISO 10993 membrane (blood path, indirect) 5. Identification of Predicate Device Predicate Device 510(k) Number: K072988 Product Name: Nipro Transducer Protector TP-SURE Manufacturer: NIPRO MEDICAL CORPORATION 6. Non-Clinical Test Concl… | 2008 |
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 42 years and passes through 4 companies; a new generation was cleared every 16.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All FIB devicesFIB Protector, Transducer, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 NovaLine SP-C35 Transducer Protector 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240164: NovaLine SP-C35 Transducer Protector (956007).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240164
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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