# K820299: Prompt Inoculation System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Mar 15, 1982 after 39 days
- Product code: LIE (Reagent/Device, Inoculum Calibration)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K221493: MicroScan Prompt Inoculation System-D (2023), 0 descendants of its own

## Recalls of this device
- Dec 13, 2019 · Class II · Z-1674-2020: 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 r
- Sep 27, 2006 · Not classified · Z-0247-2007: Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

Source page: https://510kreport.com/device/K820299
Methodology: https://510kreport.com/methodology