510(k) · Cleared
ClearedMicrojet Crono
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 Apr 26, 2002 as substantially equivalent to K982838 (Sims Deltec, Inc., 1998) after a 211-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.
- Decided
- Apr 26, 2002
- Review
- 211 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982838 (1998). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK982838 Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. · 1998 · Recalled
- This deviceK013234 Microjet CronoCane S.R.L. · 2002
- Descendant · cites it directly · 5 of its ownK041414 Crono and Crono, Model 30Cane S.R.L. · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK052218 Crono Five and Crono Pca 50Cane S.R.L. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK052217 Crono Super PidCane S.R.L. · 2005 · Recalled
- Descendant · 3 generations on · 1 of its ownK091042 Crono S-Pid 50Cane S.R.L. · 2009
- Descendant · 4 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041414Crono and Crono, Model 30Cane S.R.L. · 2004 · cites it directly5descendants
- K052218Crono Five and Crono Pca 50Cane S.R.L. · 2005 · 2 generations on2descendants
- K052217Crono Super PidCane S.R.L. · 2005 · 2 generations on2descendants
- K091042Crono S-Pid 50Cane S.R.L. · 2009 · 3 generations on1descendant
- K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400 | Sims Deltec, Inc. | 1998 | 2 |
| 0 (this device) | K013234 | Microjet Crono | Cane S.R.L. | 2002 | — |
| +1 | K041414 | Crono and Crono, Model 30 | Cane S.R.L. | 2004 | 1 |
| +2 | K052218 | Crono Five and Crono Pca 50 | Cane S.R.L. | 2005 | 1 |
| +2 | K052217 | Crono Super Pid | Cane S.R.L. | 2005 | 1 |
| +3 | K091042 | Crono S-Pid 50 | Cane S.R.L. | 2009 | — |
| +4 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400Summary page 1…e: Ambulatory Infusion Pump . Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy 1 Ambulatory Infusion Pump , Sims Deltec, Inc., K982838 . Indications for Use (intended use) The portable Crono infusion device has been designed only for use in subcutaneous infusion… | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041414 | Crono and Crono, Model 30 | 2004 | 5 |
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?
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 Microjet Crono ambulatory infusion pump device has been designed for use in subcutaneous infusion of prescribed liquid medicines.
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/K013234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013234: Microjet Crono.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013234
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026