510(k) Report

510(k) · Cleared

Cleared

Pasco Mic and Mic/ID Panels, Gemifloxacin

K031727510(k) TraditionalCleared Jul 30, 200357-day reviewClass II21 CFR 866.1640

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

Pasco Laboratories, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on Jul 30, 2003 as substantially equivalent to K030933 (Pasco Laboratories, Inc., 2003) and 29 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided
Jul 30, 2003
Review
57 days
Class
Class II
Product code
JWY
Recalls
None
Predicates
30

Its longest line of descent runs back 1 generation to K946126 (1995). 30 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2002: 1 other ancestor2001: 2 other ancestors2000: 5 other ancestors1999: 19 other ancestors2003: 1 descendant clearedK946126 · Pasco Mic and Mic/ID Panels · Pasco Laboratories, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 29 other ancestors 1 generation forward: 1 descendant K946126 · Pasco Mic and Mic/ID Panels · Pasco Laboratories, Inc. · 19950
  1. Root · 1 generation backK946126 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 1995
  2. This deviceK031727 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 1 of 1 · See all
  • 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
−1K946126Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.1995—
0 (this device)K031727Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc.2003—
+1K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
1999190
200050
200120
200210
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K031727, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWY? 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 JWY device

  1. #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 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? (30)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K030933Pasco Mic and Mic/ID Panels
Summary page 1
…est Microbiology Panel #83 SUBSTANTIAL EQUIVALENCE: In review of previous 5 1O(k) notifications for the Pasco MIC and MIC/ID panel: K030933, May 1,2003 RE: Moxifloxacin; K030620, April 14,2003 RE: Gatifloxacin; KO1 1116, April 24,2001 RE: ESBL Confirmatory Test; K01050…
Pasco Laboratories, Inc.2003—
*K030620Pasco Mic and Mic/ID Panels
Summary page 1
…Microbiology Panel #83 SUBSTANTIAL EQUIVALENCE: In review of previous 5 1O(k) notifications for the Pasco MIC and MIC/ID panel: K030933, May 1,2003 RE: Moxifloxacin; K030620, April 14,2003 RE: Gatifloxacin; KO1 1116, April 24,2001 RE: ESBL Confirmatory Test; K010508, April 23,2001 RE: ESBL Screen Test;…
Pasco Laboratories, Inc.2003—
*K011116Pasco Mic and Mic/ID Panels Inclusion of Esbl Confirmatory TestPasco Laboratories, Inc.2001—
*K010508Pasco Mic and Mic/ID Panels
Summary page 1
…ns for the Pasco MIC and MIC/ID panel: K030933, May 1,2003 RE: Moxifloxacin; K030620, April 14,2003 RE: Gatifloxacin; KO1 1116, April 24,2001 RE: ESBL Confirmatory Test; K010508, April 23,2001 RE: ESBL Screen Test; K020331, March 20,2002 RE: Ertapenem; KOO1953, August 10, 2000 RE: Amoxicillin; K001887, Aug…
Pasco Laboratories, Inc.20018
*K020331Pasco Mic and Mic/ID Panels
Summary page 1
…3, May 1,2003 RE: Moxifloxacin; K030620, April 14,2003 RE: Gatifloxacin; KO1 1116, April 24,2001 RE: ESBL Confirmatory Test; K010508, April 23,2001 RE: ESBL Screen Test; K020331, March 20,2002 RE: Ertapenem; KOO1953, August 10, 2000 RE: Amoxicillin; K001887, August 9,2000 RE: Ampicillin; KOO1721, August 4,…
Pasco Laboratories, Inc.2002—
*K001953Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2000—
*K001887Modification to Pasco Mic and Mic/ID Panels
Summary page 1
…6, April 24,2001 RE: ESBL Confirmatory Test; K010508, April 23,2001 RE: ESBL Screen Test; K020331, March 20,2002 RE: Ertapenem; KOO1953, August 10, 2000 RE: Amoxicillin; K001887, August 9,2000 RE: Ampicillin; KOO1721, August 4, 2000 RE: Clarithromycin; KO0 1612, July 18,2000 RE: Linezolid; KO015 16, July 1…
Pasco Laboratories, Inc.2000—
*K001721Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2000—
*K001612Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2000—
*K001516Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.2000—
*K992853Pasco Mic and Mic/ID Panels, Cefdinir
Summary page 1
…illin; K001887, August 9,2000 RE: Ampicillin; KOO1721, August 4, 2000 RE: Clarithromycin; KO0 1612, July 18,2000 RE: Linezolid; KO015 16, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid;…
Pasco Laboratories, Inc.1999—
*K992726Pasco Mic and Mic/ID Panels, Quinupristin/Dalfopristin for Nonfastidious Organisms
Summary page 1
…llin; KOO1721, August 4, 2000 RE: Clarithromycin; KO0 1612, July 18,2000 RE: Linezolid; KO015 16, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin…
Pasco Laboratories, Inc.1999—
*K992717Pasco Mic and Mic/ID Panels,Quinupristin/Dalfopristin
Summary page 1
…2, July 18,2000 RE: Linezolid; KO015 16, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, Oc…
Pasco Laboratories, Inc.1999—
*K992646Pasco Mic and Mic/ID Panels, Penicillin
Summary page 1
…July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992…
Pasco Laboratories, Inc.1999—
*K992647Pasco Mic and Mic/ID Panels, Erythromycin
Summary page 1
…November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K99…
Pasco Laboratories, Inc.1999—
*K992593Pasco Mic and Mic/ID Panels, Chloramphenicol
Summary page 1
…mber 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K9925…
Pasco Laboratories, Inc.1999—
*K992562Pasco Mic and Mic/ID Panels, Ceftriaxone
Summary page 1
…2717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546…
Pasco Laboratories, Inc.1999—
*K992568Pasco Mic and Mic/ID Panels, Cefotaxime
Summary page 1
…6, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420,…
Pasco Laboratories, Inc.1999—
*K992507Pasco Mic and Mic/ID Panels, Trovafloxacin
Summary page 1
…7, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27,1999 RE: Sparfloxacin; K99229…
Pasco Laboratories, Inc.1999—
*K992546Pasco Mic and Mic/ID Panels, Meropenem
Summary page 1
…, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27,1999 RE: Sparfloxacin; K992296, September 2 1,1999 RE: Vancomycin; K992297…
Pasco Laboratories, Inc.1999—
*K992420Modification of Pasco Mic and Mic/ID Panels
Summary page 1
…992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27,1999 RE: Sparfloxacin; K992296, September 2 1,1999 RE: Vancomycin; K992297, September 3,1999 RE: Levofloxacin; K992…
Pasco Laboratories, Inc.1999—
*K992296Pasco Mic and Mic/ID Panels, Vancomycin
Summary page 1
…2568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27,1999 RE: Sparfloxacin; K992296, September 2 1,1999 RE: Vancomycin; K992297, September 3,1999 RE: Levofloxacin; K992 143, September 16,1999 RE: Clindamycin; K992…
Pasco Laboratories, Inc.1999—
*K992297Pasco Mic and Mic/ID Panels, Levofloxacin
Summary page 1
…07, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27,1999 RE: Sparfloxacin; K992296, September 2 1,1999 RE: Vancomycin; K992297, September 3,1999 RE: Levofloxacin; K992 143, September 16,1999 RE: Clindamycin; K992 108, September 3,1999 RE: Cefepime; K992076…
Pasco Laboratories, Inc.1999—
*K992143Modification to Pasco Mic and Mic/ID Panels (Clindamycin)
Summary page 1
…546, October 12, 1999 RE: Meropenem; K992420, September 27,1999 RE: Sparfloxacin; K992296, September 2 1,1999 RE: Vancomycin; K992297, September 3,1999 RE: Levofloxacin; K992 143, September 16,1999 RE: Clindamycin; K992 108, September 3,1999 RE: Cefepime; K992076, August 30,1999 RE: Cefuroxime; K992059, Aug…
Pasco Laboratories, Inc.1999—
*K992108Pasco Mic and Mic/ID Panels (Cefepime)
Summary page 1
…September 27,1999 RE: Sparfloxacin; K992296, September 2 1,1999 RE: Vancomycin; K992297, September 3,1999 RE: Levofloxacin; K992 143, September 16,1999 RE: Clindamycin; K992 108, September 3,1999 RE: Cefepime; K992076, August 30,1999 RE: Cefuroxime; K992059, August 30,1999 RE: Imipenem; K992077, September…
Pasco Laboratories, Inc.1999—
*K992076Pasco Mic and Mic/ID Panels (Cefuroxime)
Summary page 1
…296, September 2 1,1999 RE: Vancomycin; K992297, September 3,1999 RE: Levofloxacin; K992 143, September 16,1999 RE: Clindamycin; K992 108, September 3,1999 RE: Cefepime; K992076, August 30,1999 RE: Cefuroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 2…
Pasco Laboratories, Inc.1999—
*K992059Pasco Mic and Mic/ID Panels
Summary page 1
…K992297, September 3,1999 RE: Levofloxacin; K992 143, September 16,1999 RE: Clindamycin; K992 108, September 3,1999 RE: Cefepime; K992076, August 30,1999 RE: Cefuroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: AmoxicillidClavulanic Acid;…
Pasco Laboratories, Inc.1999—
*K992077Pasco Mic and Mic/ID Panels (Ofloxacin)
Summary page 1
…acin; K992 143, September 16,1999 RE: Clindamycin; K992 108, September 3,1999 RE: Cefepime; K992076, August 30,1999 RE: Cefuroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: AmoxicillidClavulanic Acid; and K946126, January 17, 1995 RE: Dete…
Pasco Laboratories, Inc.1999—
*K991925Pasco Mic and Mic/ID Panels
Summary page 1
…damycin; K992 108, September 3,1999 RE: Cefepime; K992076, August 30,1999 RE: Cefuroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: AmoxicillidClavulanic Acid; and K946126, January 17, 1995 RE: Detection of resistant pneumococci), the FDA h…
Pasco Laboratories, Inc.1999—
*K946126Pasco Mic and Mic/ID Panels
Summary page 1
…gust 30,1999 RE: Cefuroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: AmoxicillidClavulanic Acid; and K946126, January 17, 1995 RE: Detection of resistant pneumococci), the FDA has determined the Pasco panels to be substantially equivalent…
Pasco Laboratories, Inc.1995—

Also cleared against K030933: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc.20030

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 30 ancestors has a recall of any class.
  • Of its descendants, K033119 (Pasco Laboratories, Inc., 2003) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K030933.

How does its category compare?

All JWY devices

JWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWY

14in 2025

2008: 62009: 22010: 42011: 42012: 12014: 62015: 92016: 42017: 142018: 122019: 182020: 52021: 52023: 72024: 62025: 142026 (partial year): 2
2007high 18 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWY

106in 2025

2008: 85 days median2010: 73 days median2011: 125 days median2014: 106 days median2015: 90 days median2016: 88 days median2017: 61 days median2018: 51 days median2019: 60 days median2020: 66 days median2021: 266 days median2023: 85 days median2024: 90 days median2025: 106 days median
2007high 266 (2021) · low 51 (2018)2026

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

Recalls per year · JWY

31in 2022

2008: 12011: 32014: 52015: 6, 4 Class I2017: 22022: 31, 9 Class I
2007high 31 (2022) · low 0 (2007)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · JWY

1in 2024

2008: 12009: 12014: 42015: 112016: 202017: 92018: 132019: 102020: 202021: 412022: 112023: 92024: 1
2007high 41 (2021) · low 0 (2007)2025

MAUDE reports naming product code JWY, 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—00
200868511
20092—01
201047300
2011412530
20121—00
20130—00
2014610654
20159906 (4)11
2016488020
2017146129
20181251013
20191860010
2020566020
20215266041
20220—31 (9)11
202378509
202469001
20251410600
20262—0—

What is it indicated for?

Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the BreakpoindID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of the antimicrobial Gemifloxacin at…

Read the full statement (132 words)

Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the BreakpoindID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of the antimicrobial Gemifloxacin at concentrations of 0.015 .. 4 mcg/ml to Pasco Panels. Gemifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert-forthis antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-negative microorganisms

Klebsiella pneumoniae

Active In Vitro but their clinical significance is unknown

Aerobic Gram-positive microorganisms

Staphylococcus aureus (methicillin-susceptiblestrains only)

Aerobic Gram-negative microorganisms

Acinetobacter lwoffi

Klebsiella oxytoca

Proteus vulgaris

Indications for use as stated in the FDA summary.

Also cleared against K030933

1 other device cites the same predicate.

  • K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003

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
  • K031205Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003

Recent decisions in JWY

The JWY category page

  • K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026
  • K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l. · 2026
  • K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l. · 2025
  • K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of…Thermo Fisher Scientific · 2025
  • K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution…Thermo Fisher Scientific · 2025

https://510kreport.com/device/K031727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031727: Pasco Mic and Mic/ID Panels, Gemifloxacin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031727

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026