510(k) · Cleared
Recalled · Class II · 2013Crono and Crono, Model 30
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 Jul 8, 2004 as substantially equivalent to K013234 (Cane S.R.L., 2002) after a 42-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 8, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982838 (1998). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK982838 Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. · 1998 · Recalled
- 1 generation backK013234 Microjet CronoCane S.R.L. · 2002
- This deviceK041414 Crono and Crono, Model 30Cane S.R.L. · 2004
- Descendant · cites it directly · 2 of its ownK052218 Crono Five and Crono Pca 50Cane S.R.L. · 2005 · Recalled
- Descendant · cites it directly · 2 of its ownK052217 Crono Super PidCane S.R.L. · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK091042 Crono S-Pid 50Cane S.R.L. · 2009
- Descendant · 3 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
- Descendant · cites it directly · 0 of its ownK052219 Crono GO.Cane S.R.L. · 2005 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K052218Crono Five and Crono Pca 50Cane S.R.L. · 2005 · cites it directly2descendants
- K052217Crono Super PidCane S.R.L. · 2005 · cites it directly2descendants
- K091042Crono S-Pid 50Cane S.R.L. · 2009 · 2 generations on1descendant
- K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025 · 3 generations on0descendants
- K052219Crono GO.Cane S.R.L. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400 | Sims Deltec, Inc. | 1998 | 2 |
| −1 | K013234 | Microjet Crono | Cane S.R.L. | 2002 | — |
| 0 (this device) | K041414 | Crono and Crono, Model 30 | Cane S.R.L. | 2004 | — |
| +1 | K052218 | Crono Five and Crono Pca 50 | Cane S.R.L. | 2005 | 1 |
| +1 | K052217 | Crono Super Pid | Cane S.R.L. | 2005 | 1 |
| +2 | K091042 | Crono S-Pid 50 | Cane S.R.L. | 2009 | — |
| +3 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
| +1 | K052219 | Crono GO. | Cane S.R.L. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K013234 | Microjet CronoSummary page 1…is similar in function and design to the Crono cleared under 510(k) number K013234 3. Indications for Use (intended use) The portable Crono infusion devices have been designed for use in subcutaneous infusio… | 2002 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2013 | Class II | Z-0099-2015 | Device Design | Product has the potential to have a clear debris on the tip of the needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K052218 (Cane S.R.L., 2005) has gone furthest, with 2 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.
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 and Crono 30 ambulatory infusion pump devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041414: Crono and Crono, Model 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041414
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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