510(k) Report

510(k) · Cleared

Recalled · 2008

Pasco Mic and Mic/ID Panels

K010508510(k) TraditionalCleared Apr 23, 200161-day reviewClass II21 CFR 866.1640Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pasco Laboratories, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial

Cleared on Apr 23, 2001 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 8 times.

Decided
Apr 23, 2001
Review
61 days
Class
Class II
Product code
LTT
Recalls
8
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared200020052010201520202025
  1. This deviceK010508 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK031727 Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK033119 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K031727Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc. · 2003 · cites it directly1descendant
  • K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010508Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2001—
+1K031727Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc.2003—
+1K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
FIG. 1 — Lineage of K010508, 2001–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LTT? 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 LTT device

  1. #1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031727Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc.20031
K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 22, 2008Not classifiedZ-1463-2008Device DesignThe 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, 2008Not classifiedZ-1469-2008Device DesignThe 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, 2008Not classifiedZ-1468-2008Device DesignThe 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, 2008Not classifiedZ-1467-2008Device DesignThe 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, 2008Not classifiedZ-1464-2008Device DesignThe 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, 2008Not classifiedZ-1470-2008Device DesignThe 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, 2008Not classifiedZ-1466-2008Device DesignThe 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, 2008Not classifiedZ-1465-2008Device DesignThe 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.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K031727 (Pasco Laboratories, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LTT devices

LTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTT

3in 2025

2009: 22010: 12011: 12013: 22015: 12017: 42019: 12020: 42025: 3
2007high 4 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTT

219in 2025

2017: 132 days median2020: 90 days median2025: 219 days median
2007high 219 (2025) · low 90 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LTT

7in 2015

2015: 7
2007high 7 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LTT

3in 2017

2007: 72008: 42009: 12010: 12011: 12013: 52014: 92015: 102016: 12017: 3
2007high 10 (2015) · low 0 (2012)2025

MAUDE reports naming product code LTT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—07
20080—04
20092—01
20101—01
20111—01
20120—00
20132—05
20140—09
20151—710
20160—01
2017413203
20180—00
20191—00
202049000
20210—00
20220—00
20230—00
20240—00
2025321900
20260—0—

More from Pasco Laboratories, Inc.

76 FDA decisions under this applicant name. See the company

  • K042331Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2004
  • K041776Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2004
  • K041214Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2004
  • K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003
  • K031727Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc. · 2003

Recent decisions in LTT

The LTT category page

  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc. · 2025
  • K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc. · 2025
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025
  • K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. · 20201 recall
  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020

https://510kreport.com/device/K010508 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010508: Pasco Mic and Mic/ID Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010508

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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