510(k) · Cleared
ClearedMicrojet Crono Pca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cane S.R.L. · MEA Pump, Infusion, Pca
Cleared on May 8, 2002 as substantially equivalent to K982839 (Sims Deltec, Inc., 1998) after a 173-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- May 8, 2002
- Review
- 173 days
- Class
- Class II
- Product code
- MEA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982839 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK982839 Cadd-Legacy Pca Ambulatory Infusion System, Model 6300Sims Deltec, Inc. · 1998
- This deviceK013822 Microjet Crono PcaCane S.R.L. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982839 | Cadd-Legacy Pca Ambulatory Infusion System, Model 6300 | Sims Deltec, Inc. | 1998 | — |
| 0 (this device) | K013822 | Microjet Crono Pca | Cane S.R.L. | 2002 | — |
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 MEA? 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 |
|---|---|---|---|
| * | K982839 | Cadd-Legacy Pca Ambulatory Infusion System, Model 6300Summary page 1…Infusion Pump . Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy PCA Model 6300 Ambulatory Infusion Pump , Sims Deltec, Inc., K982839 . Indications for Use (intended use) The portable Crono infusion device has been designed for use in intravenous or subcutaneous… | 1998 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K982839.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.
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/K013822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013822: Microjet Crono Pca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013822
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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