510(k) · Cleared
ClearedFlocap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxtec, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Mar 28, 2014 as substantially equivalent to K021576 (Mercury Medical, 2002) after a 130-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Mar 28, 2014
- Review
- 130 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894053 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
- 1 generation backK021576 Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical · 2002
- This deviceK133540 FlocapMaxtec, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK261633 VisuBreathAffirm Medical Technologies II, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K261633VisuBreathAffirm Medical Technologies II, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894053 | 2ND Modification of Fef (TM) End-Tidal CO2 Detector | Fenem, Inc. | 1989 | — |
| −1 | K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370 | Mercury Medical | 2002 | — |
| 0 (this device) | K133540 | Flocap | Maxtec, Inc. | 2014 | — |
| +1 | K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 CCK? 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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 |
|---|---|---|---|
| * | K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Summary page 1…: FLOCAP Common/Usual Name: ' CO; detector Classification Name: Carbon dioxide gas analyzer CCK - 21 CFR 868.1400 Class 2 Predicate Devices: Mercury Medical - StatCO, — K021576 Device Description The proposed FLOCAP is comprised of several components: * Housing with standard 15 mm / 22 mm fittings 1o co… | 2002 |
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 |
|---|---|---|---|
| K261633 | VisuBreath | 2026 | 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 25 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K261633 (Affirm Medical Technologies II, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021576.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The FLOCAP is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
The FLOCAP has a visual indicator to visually detect the end of exhalation.
For use up to 24 hours.
For patients greater than 15 kg (33 lbs.)
Environment of use — hospital, sub-acute, pre-hospital, transport
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/K133540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133540: Flocap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133540
Report an extraction error
Are you the manufacturer?
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