510(k) · Cleared
Recalled · Class II · 2019Walkaway TM 40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Cleared on Nov 19, 1991 after a 235-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 11 times.
- Decided
- Nov 19, 1991
- Review
- 235 days
- Class
- Class II
- Product code
- LRG
- Recalls
- 11
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRG? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2019 | Class II | Z-1084-2022 | Mixed-up of materials/components | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere |
| Oct 21, 2019 | Class II | Z-1085-2022 | Mixed-up of materials/components | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere |
| Oct 21, 2019 | Class II | Z-1088-2022 | Mixed-up of materials/components | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere |
| Oct 21, 2019 | Class II | Z-1087-2022 | Mixed-up of materials/components | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere |
| Oct 21, 2019 | Class II | Z-1083-2022 | Mixed-up of materials/components | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere |
| Oct 21, 2019 | Class II | Z-1086-2022 | Mixed-up of materials/components | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere |
| Sep 4, 2019 | Class II | Z-1370-2021 | Process control | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. |
| Sep 4, 2019 | Class II | Z-1371-2021 | Process control | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. |
| Sep 4, 2019 | Class II | Z-1372-2021 | Process control | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. |
| Sep 4, 2019 | Class II | Z-1373-2021 | Process control | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. |
| Jun 2, 2014 | Class II | Z-1990-2014 | Component design/selection | Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LRG devicesLRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRG
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LRG
144in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRG
1in 2025
MAUDE reports naming product code LRG, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 4 | 144 | 0 | 11 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K911400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911400: Walkaway TM 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911400
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026