510(k) · Cleared
ClearedColibrí System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Wasp Srl · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Oct 5, 2022 as substantially equivalent to K103752 (bioMerieux, Inc., 2011) after a 222-day review. Its family tree reaches back 6 generations to 2003. 2 later devices descend from it.
- Decided
- Oct 5, 2022
- Review
- 222 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K032788 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- 5 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
- 4 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- 3 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
- 2 generations backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
- 1 generation backK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
- This deviceK220546 Colibrí SystemCopan Wasp Srl · 2022
- Descendant · cites it directly · 1 of its ownK223245 ColibríCopan Wasp Srl · 2023
- Descendant · 2 generations on · 0 of its ownK232756 ColibríCopan Wasp Srl · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| −5 | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | 1 |
| −4 | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| −3 | K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | 2009 | — |
| −2 | K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | 2009 | — |
| −1 | K103752 | Vitek 2 Systems (PC) 5.02 Software | bioMerieux, Inc. | 2011 | — |
| 0 (this device) | K220546 | Colibrí System | Copan Wasp Srl | 2022 | — |
| +1 | K223245 | Colibrí | Copan Wasp Srl | 2023 | — |
| +2 | K232756 | Colibrí | Copan Wasp Srl | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 LON? 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 LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 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 |
|---|---|---|---|
| * | K103752 | Vitek 2 Systems (PC) 5.02 SoftwareSummary page 5…m Negative Imipenem & VITEK 2 Systems (PC) 5.02 Software 510(K) Number K103752 No reference Devices were used in this submission. IV. Device Description The Copan Colibrí System is designe… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223245 | Colibrí | 2023 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K223245 (Copan Wasp Srl, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K103752.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, 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 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
The Colibri™ System is an in vitro diagnostic device comprised of the Colibri™ Vision System and Colibri™ Preparation Station for use with the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and with the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture…
Read the full statement (207 words)
The Colibri™ System is an in vitro diagnostic device comprised of the Colibri™ Vision System and Colibri™ Preparation Station for use with the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and with the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media. The Colibri™ System is a semi-automated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.
The Colibri™ software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers.
Bacterial suspensions for AST and purity plates are identified by barcode label.
The Colibri™ System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bacterial infections.
The Colibri™ System has not been validated for use in the identification or processing of yeast species, molds, Nocardia, or mycobacteria.
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/K220546 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220546: Colibrí System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220546
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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