510(k) · Cleared
Recalled · Class II · 2019Prompt Inoculation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · LIE Reagent/Device, Inoculum Calibration
Cleared on Mar 15, 1982 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 15, 1982
- Review
- 39 days
- Class
- Class II
- Product code
- LIE
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK820299 Prompt Inoculation System3M Company · 1982
- Descendant · cites it directly · 0 of its ownK221493 MicroScan Prompt Inoculation System-DBeckman Coulter, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221493MicroScan Prompt Inoculation System-DBeckman Coulter, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820299 | Prompt Inoculation System | 3M Company | 1982 | — |
| +1 | K221493 | MicroScan Prompt Inoculation System-D | Beckman Coulter, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 LIE? 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 LIE device
- #1 K221493 MicroScan Prompt Inoculation System-Dscore 5.1 · 1 generation · no Class I recall
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-D | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2019 | Class II | Z-1674-2020 | Nonconforming Material/Component | Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications… |
| Sep 27, 2006 | Not classified | Z-0247-2007 | Other | Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K221493 (Beckman Coulter, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LIE devicesLIE Reagent/Device, Inoculum Calibration: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LIE
Too few LIE 510(k)s in any year since 2007 to give a median.
Recalls per year · LIE
No recall names LIE since 2007.
Adverse event reports per year · LIE
No MAUDE report names LIE since 2007.
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 | 2 | — | 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K820299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820299: Prompt Inoculation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820299
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026