# K010508: Pasco Mic and Mic/ID Panels

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Apr 23, 2001 after 61 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K031727: Pasco Mic and Mic/ID Panels, Gemifloxacin (2003), 1 descendant of its own
- K033119: Pasco Mic and Mic/ID Panels (2003), 0 descendants of its own

## Recalls of this device
- Feb 22, 2008 · Not classified · Z-1463-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1469-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1468-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1467-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1464-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1470-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1466-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1465-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.

Source page: https://510kreport.com/device/K010508
Methodology: https://510kreport.com/methodology