510(k) · Cleared
ClearedCrono S-Pid 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cane S.R.L. · FRN Pump, Infusion
Cleared on May 12, 2009 as substantially equivalent to K052217 (Cane S.R.L., 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- May 12, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982838 (1998). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK982838 Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. · 1998 · Recalled
- 3 generations backK013234 Microjet CronoCane S.R.L. · 2002
- 2 generations backK041414 Crono and Crono, Model 30Cane S.R.L. · 2004 · Recalled
- 1 generation backK052217 Crono Super PidCane S.R.L. · 2005 · Recalled
- This deviceK091042 Crono S-Pid 50Cane S.R.L. · 2009
- Descendant · cites it directly · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400 | Sims Deltec, Inc. | 1998 | 2 |
| −3 | K013234 | Microjet Crono | Cane S.R.L. | 2002 | — |
| −2 | K041414 | Crono and Crono, Model 30 | Cane S.R.L. | 2004 | 1 |
| −1 | K052217 | Crono Super Pid | Cane S.R.L. | 2005 | 1 |
| 0 (this device) | K091042 | Crono S-Pid 50 | Cane S.R.L. | 2009 | — |
| +1 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K052217 | Crono Super PidSummary page 1…mmon/Usual Name: Ambulatory Infusion Pump. 2. Equivalent legally marketed devices This product is similar infunction and design to the pumps cleared under 510(k) number K052217 (Crono Super PID) and K052218 (Crono PCA 50). 3. Indications for Use (intended use) The portable Crono S-PID 50 infusion devices… | 2005 |
| * | K052218 | Crono Five and Crono Pca 50Summary page 1…fusion Pump. 2. Equivalent legally marketed devices This product is similar infunction and design to the pumps cleared under 510(k) number K052217 (Crono Super PID) and K052218 (Crono PCA 50). 3. Indications for Use (intended use) The portable Crono S-PID 50 infusion devices have been designed for use in… | 2005 |
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 |
|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | 2025 | 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 11 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K251105 (Emed Technologies Corporation, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
the Crono S-PID 50 has been designed for use in subcutaneous infusion of prescribed liquid medicines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091042: Crono S-Pid 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091042
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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