510(k) · Cleared
ClearedLifeguard Backtrack B90 Breath Alcohol Tester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifeloc Technologies, Inc. · DJZ Devices, Breath Trapping, Alcohol
Cleared on Jul 23, 2009 as substantially equivalent to K063443 (Drager Safety, 2008) and 1 other predicate after a 122-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jul 23, 2009
- Review
- 122 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K041334 (2004). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 2 generations backK052804 Breathkey Model G10/Breathkey Model G30XOmega Point Systems, LLC · 2005
- 1 generation backK063443 Draeger Alcotest 6510Drager Safety · 2008
- This deviceK090766 Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| −2 | K052804 | Breathkey Model G10/Breathkey Model G30X | Omega Point Systems, LLC | 2005 | — |
| −1 | K063443 | Draeger Alcotest 6510 | Drager Safety | 2008 | — |
| 0 (this device) | K090766 | Lifeguard Backtrack B90 Breath Alcohol Tester | Lifeloc Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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 DJZ? 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? (2)
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 |
|---|---|---|---|
| * | K063443 | Draeger Alcotest 6510Summary page 1…al settings. Predicate Device Summary The LifeGuard and BacTrack B90 devices are claimed to be substantially equivalent to these legally marketed devices: Drager 6510 (k063443) and AlcoHawk PT-500 (k080848). Description of Device The LifeGuard product is a breath alcohol detector designed to sample the… | 2008 |
| * | K080848 | Alcohawk Model PT500 Digital Alcohol DetectorSummary page 1…Summary The LifeGuard and BacTrack B90 devices are claimed to be substantially equivalent to these legally marketed devices: Drager 6510 (k063443) and AlcoHawk PT-500 (k080848). Description of Device The LifeGuard product is a breath alcohol detector designed to sample the patient’s deep lung air in or… | 2008 |
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?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DJZ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DJZ
240in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJZ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJZ
3in 2025
MAUDE reports naming product code DJZ, 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 | 2 | — | 1 | 2 |
| 2008 | 5 | 149 | 0 | 0 |
| 2009 | 5 | 122 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 240 | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication.
The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians.
The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others.
The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.
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/K090766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090766: Lifeguard Backtrack B90 Breath Alcohol Tester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090766
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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