510(k) · Cleared

Cleared

Pasco Mic and Mic/ID Panels

K033119510(k) TraditionalCleared Nov 18, 200349-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 Nov 18, 2003 as substantially equivalent to K032259 (Bd Diagnostic Systems, 2003) and 34 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1995.

Decided: Nov 18, 2003
Review: 49 days
Class: Class II
Product code: JWY
Recalls: None
Predicates: 35

Its longest line of descent runs back 2 generations to K946126 (1995). 35 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK946126 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 1995
1 generation backK031727 Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc. · 2003
This deviceK033119 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K946126	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	1995	—
−1	K031727	Pasco Mic and Mic/ID Panels, Gemifloxacin	Pasco Laboratories, Inc.	2003	—
0 (this device)	K033119	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	19	0
2000	5	0
2001	2	0
2002	1	0
2003	6	0

FIG. 1 — Lineage of K033119, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (35)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K032259	Pasco Mic and Mic/ID Panels Summary page 1 …Test Microbiology Panel #83 SUBSTANTIAL EQUIVALENCE: In review of previous 5 1O(k) notifications for the Pasco MIC and MIC/ID panel: K032259, August 19,2003 RE: Gatifloxacin (Strep); KO325 18, September 15,2003 RE: Gemifloxacin (Strep); KO3 1727, July 30,2003 RE: Gemifl…	Bd Diagnostic Systems	2003	—
*	K032518	Pasco Mic and Mic/ID Panels, Gemifloxacin (Strep)	Bd Diagnostic Systems	2003	—
*	K031727	Pasco Mic and Mic/ID Panels, Gemifloxacin	Pasco Laboratories, Inc.	2003	—
*	K031205	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2003	—
*	K031103	Pasco Mic and Mic/ID Panels (Ertapenem)	Pasco Laboratories, Inc.	2003	—
*	K030933	Pasco Mic and Mic/ID Panels Summary page 1 …325 18, September 15,2003 RE: Gemifloxacin (Strep); KO3 1727, July 30,2003 RE: Gemifloxacin; KO3 1205, June 13, 2003 RE: Linezolid; KO3 1103, June 12,2003 RE: Ertapenem; K030933, May 1,2003 RE: Moxifloxacin; K030620, April 14, 2003 RE: Gatifloxacin; KO1 1116, April 24, 2001 RE: ESBL Confirmatory Test; K010…	Pasco Laboratories, Inc.	2003	—
*	K030620	Pasco Mic and Mic/ID Panels Summary page 1 …acin (Strep); KO3 1727, July 30,2003 RE: Gemifloxacin; KO3 1205, June 13, 2003 RE: Linezolid; KO3 1103, June 12,2003 RE: Ertapenem; 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 Tes…	Pasco Laboratories, Inc.	2003	—
*	K011116	Pasco Mic and Mic/ID Panels Inclusion of Esbl Confirmatory Test	Pasco Laboratories, Inc.	2001	—
*	K010508	Pasco Mic and Mic/ID Panels Summary page 1 …O3 1103, June 12,2003 RE: Ertapenem; 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; KO01887, Augu…	Pasco Laboratories, Inc.	2001	8
*	K020331	Pasco Mic and Mic/ID Panels Summary page 1 …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; KO01887, August 9,2000 RE: Ampicillin; KO0 1721, August 4,…	Pasco Laboratories, Inc.	2002	—
*	K001953	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2000	—
*	K001887	Modification to Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2000	—
*	K001721	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2000	—
*	K001612	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2000	—
*	K001516	Pasco Mic and Mic/ID Panels	Pasco Laboratories, Inc.	2000	—
*	K992853	Pasco Mic and Mic/ID Panels, Cefdinir Summary page 1 …lin; KO01887, August 9,2000 RE: Ampicillin; KO0 1721, August 4, 2000 RE: Clarithromycin; KO0 1612, July 18, 2000 RE: Linezolid; KO0 1516, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K9927 17, November 2, 1999 RE: Synercid;…	Pasco Laboratories, Inc.	1999	—
*	K992726	Pasco Mic and Mic/ID Panels, Quinupristin/Dalfopristin for Nonfastidious Organisms Summary page 1 …in; KO0 1721, August 4, 2000 RE: Clarithromycin; KO0 1612, July 18, 2000 RE: Linezolid; KO0 1516, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K9927 17, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicilli…	Pasco Laboratories, Inc.	1999	—
*	K992717	Pasco Mic and Mic/ID Panels,Quinupristin/Dalfopristin Summary page 1 …, July 18, 2000 RE: Linezolid; KO0 1516, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K9927 17, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, Oc…	Pasco Laboratories, Inc.	1999	—
*	K992646	Pasco 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); K9927 17, 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	—
*	K992647	Pasco Mic and Mic/ID Panels, Erythromycin Summary page 1 …ovember 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K9927 17, 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: Cefiriaxone; K99…	Pasco Laboratories, Inc.	1999	—
*	K992593	Pasco Mic and Mic/ID Panels, Chloramphenicol Summary page 1 …ber 3, 1999 RE: Synercid (non-fastidious); K9927 17, 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: Cefiriaxone; K992568, October 14, 1999 RE: Cefotaxime; K9925…	Pasco Laboratories, Inc.	1999	—
*	K992562	Pasco Mic and Mic/ID Panels, Ceftriaxone Summary page 1 …7 17, 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: Cefiriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18,1999 RE: Trovafloxacin; K992546,…	Pasco Laboratories, Inc.	1999	—
*	K992568	Pasco 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: Cefiriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18,1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, S…	Pasco Laboratories, Inc.	1999	—
*	K992507	Pasco 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: Cefiriaxone; 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	—
*	K992546	Pasco Mic and Mic/ID Panels, Meropenem Summary page 1 …3, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Cefiriaxone; 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; K9922…	Pasco Laboratories, Inc.	1999	—
*	K992420	Modification of Pasco Mic and Mic/ID Panels Summary page 1 …K992562, October 13, 1999 RE: Cefiriaxone; 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; K…	Pasco Laboratories, Inc.	1999	—
*	K992296	Pasco 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; K992143, September 16, 1999 RE: Clindamycin; K9…	Pasco Laboratories, Inc.	1999	—
*	K992297	Pasco Mic and Mic/ID Panels, Levofloxacin Summary page 1 …7, 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; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K99207…	Pasco Laboratories, Inc.	1999	—
*	K992143	Modification to Pasco Mic and Mic/ID Panels (Clindamycin) Summary page 1 …, October 12, 1999 RE: Meropenem; K992420, September 27, 1999 RE: Sparfloxacin; K992296, September 2 1, 1999 RE: Vancomycin; K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cehroxime; K992059, Au…	Pasco Laboratories, Inc.	1999	—
*	K992108	Pasco Mic and Mic/ID Panels (Cefepime) Summary page 1 …ptember 27, 1999 RE: Sparfloxacin; K992296, September 2 1, 1999 RE: Vancomycin; K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cehroxime; K992059, August 30,1999 RE: Imipenem; K992077, September…	Pasco Laboratories, Inc.	1999	—
*	K992076	Pasco Mic and Mic/ID Panels (Cefuroxime) Summary page 1 …6, September 2 1, 1999 RE: Vancomycin; K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cehroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 2…	Pasco Laboratories, Inc.	1999	—
*	K992059	Pasco Mic and Mic/ID Panels Summary page 1 …992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cehroxime; K992059, August 30,1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: AmoxicillidClavulanic Acid;…	Pasco Laboratories, Inc.	1999	—
*	K992077	Pasco Mic and Mic/ID Panels (Ofloxacin) Summary page 1 …acin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cehroxime; 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	—
*	K991925	Pasco Mic and Mic/ID Panels Summary page 1 …damycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cehroxime; 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	—
*	K946126	Pasco Mic and Mic/ID Panels Summary page 1 …gust 30, 1999 RE: Cehroxime; 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	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 8.5 years on median.
1 of the 35 ancestors has a recall of any class.

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

2007high 18 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWY

106in 2025

2007high 266 (2021) · low 51 (2018)2026

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

Recalls per year · JWY

31in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	6	85	1	1
2009	2	—	0	1
2010	4	73	0	0
2011	4	125	3	0
2012	1	—	0	0
2013	0	—	0	0
2014	6	106	5	4
2015	9	90	6 (4)	11
2016	4	88	0	20
2017	14	61	2	9
2018	12	51	0	13
2019	18	60	0	10
2020	5	66	0	20
2021	5	266	0	41
2022	0	—	31 (9)	11
2023	7	85	0	9
2024	6	90	0	1
2025	14	106	0	0
2026	2	—	0	—

What is it indicated for?

Pasco MIC and MICAD 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 5,10(k) notification is for the addition of the antimicrobial Daptomycin at…

Read the full statement (143 words)

This 5,10(k) notification is for the addition of the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels. Daptomycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Apainst:

Aerobic Gram-positive microorganisms

Enterococcusfaecalis (vancomycin-susceptible strains only)

Staphylococcus aureus (including methicillin-resistant strains)

Active In Vitro but their clinical simificance is unknown

Aerobic Gram-positive microorganisms

Enterococcusfaecalis (vancomycin-resistant strains)

Enterococcus fuecium (including vancomycin-resistant strains)

Stuphylococcus epidermidis (including methicillin-resistant strains)

Staphylococcus huemolyticus

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033119 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033119: 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/K033119

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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