510(k) · Cleared
ClearedColibrí
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Wasp Srl · QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Cleared on Mar 20, 2023 as substantially equivalent to K220546 (Copan Wasp Srl, 2022) after a 151-day review. Its family tree reaches back 7 generations to 2003. 1 later device descends from it.
- Decided
- Mar 20, 2023
- Review
- 151 days
- Class
- Class II
- Product code
- QQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K032788 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- 6 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
- 5 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- 4 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
- 3 generations backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
- 2 generations backK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
- 1 generation backK220546 Colibrí SystemCopan Wasp Srl · 2022
- This deviceK223245 ColibríCopan Wasp Srl · 2023
- Descendant · cites it directly · 0 of its ownK232756 ColibríCopan Wasp Srl · 2023
Most influential descendants
Showing 1 of 1 · See all- K232756ColibríCopan Wasp Srl · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| −6 | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | 1 |
| −5 | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| −4 | K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | 2009 | — |
| −3 | K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | 2009 | — |
| −2 | K103752 | Vitek 2 Systems (PC) 5.02 Software | bioMerieux, Inc. | 2011 | — |
| −1 | K220546 | Colibrí System | Copan Wasp Srl | 2022 | — |
| 0 (this device) | K223245 | Colibrí | Copan Wasp Srl | 2023 | — |
| +1 | K232756 | Colibrí | Copan Wasp Srl | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 QQV? 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 QQV device
- #1 K222563 BD Kiestra IdentifAscore 6.2 · 2 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 |
|---|---|---|---|
| * | K220546 | Colibrí SystemSummary page 5…Legally Marketed Predicate Device Device Name Colibrí System 510(K) Number K220546 No reference Devices were used in this submission. IV. Device Description The Colibrí is an instrume… | 2022 |
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 |
|---|---|---|---|
| K232756 | Colibrí | 2023 | 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 20 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K232756 (Copan Wasp Srl, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QQV devicesQQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QQV
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QQV
Too few QQV 510(k)s in any year since 2007 to give a median.
Recalls per year · QQV
No recall names QQV since 2007.
Adverse event reports per year · QQV
1in 2024
MAUDE reports naming product code QQV, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Colibrí™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for 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…
Read the full statement (204 words)
The Colibrí™ is an automated in vitro diagnostic specimen preparation system for use with WASPLab® to prepare MALDI-TOF targets for the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and microbial suspension for 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 Colibrí™ is an 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 Colibrí™ 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 Colibrí™ 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 Colibrí™ 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/K223245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223245: Colibrí.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223245
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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