Chrysalis Intelligence · Sponsors · Midmark Corporation

Midmark Corporation

Buffalo Grove, IL, US · 4 510(k) clearances · 6 recalls

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Total clearances
4
2020-08-06 → 2026-06-12
Last 12 months
2
Product codes
4
Most recent
2026-06-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class II Cardiovascular 1 2026-06-12
EIA Unit, Operative Dental Class I Dental 1 2025-11-03
FLE Sterilizer, Steam Class II General Hospital 1 2024-04-04
OAS X-Ray, Tomography, Computed, Dental Class II Radiology 1 2020-08-06
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
6
Most recent
2026-08-21
DateSeverityStatusRecall # ProductCodeReason
2026-08-21 Class II Ongoing Z-3220-2026 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe… — A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21 Class II Ongoing Z-3219-2026 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe… — A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21 Class II Ongoing Z-3218-2026 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe… — A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-08-21 Class II Ongoing Z-3217-2026 Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe… — A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
2026-07-20 Class II Ongoing Z-3013-2026 Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions star… — A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
2026-07-20 Class II Ongoing Z-3012-2026 Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions… — A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-06-12 K253196 Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) MWI Class II Cardiovascular
2025-11-03 K251626 Midmark Dental Delivery System EIA Class I Dental
2024-04-04 K233026 Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer FLE Class II General Hospital
2020-08-06 K201667 Midmark Extraoral Imaging System (EOIS) OAS Class II Radiology
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence