510(k) · Cleared
ClearedMedisystems Transducer Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · FIB Protector, Transducer, Dialysis
Cleared on Nov 24, 1989 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 24, 1989
- Review
- 53 days
- Class
- Class II
- Product code
- FIB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK895856 Medisystems Transducer ProtectorMedisystems Corp. · 1989
- Descendant · cites it directly · 2 of its ownK983076 Medisystems Transducer ProtectorMedisystems Corp. · 1998
- Descendant · 2 generations on · 1 of its ownK072988 Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008
- Descendant · 3 generations on · 0 of its ownK240164 NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK970536 Medisystems Tranducer ProtectorMedisystems Corp. · 1997
Most influential descendants
Showing 4 of 4 · See all- K983076Medisystems Transducer ProtectorMedisystems Corp. · 1998 · cites it directly2descendants
- K072988Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008 · 2 generations on1descendant
- K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024 · 3 generations on0descendants
- K970536Medisystems Tranducer ProtectorMedisystems Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895856 | Medisystems Transducer Protector | Medisystems Corp. | 1989 | — |
| +1 | K983076 | Medisystems Transducer Protector | Medisystems Corp. | 1998 | — |
| +2 | K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1 | Nipro Medical Corporation | 2008 | — |
| +3 | K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024 | — |
| +1 | K970536 | Medisystems Tranducer Protector | Medisystems Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K983076 (Medisystems Corp., 1998) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K895856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895856: Medisystems Transducer Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895856
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026