Connex Spot Monitor,901058 Vital Signs Monitor Core— 510(k) K142356

Clearance details

Applicant

Welch Allyn, Inc.

Product code

Code MWI

Device class

Class 2

Regulation

21 CFR 870.2300

Advisory panel

Cardiovascular

Date received

2014-08-25

Decision date

2014-12-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Skaneateles Falls, NY, US

• K260438 — Vital Signs Monitor (CLEO2)2026-08-14
• K253417 — Masimo Root Monitoring System2026-08-12
• K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
• K253436 — c-med0 alpha2026-04-30
• K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

• K243598 — Welch Allyn Connex® 360 (Multiple)2025-07-13
• K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)2024-12-20
• K223381 — iExaminer System with Panoptic Plus2023-03-15
• K212473 — Welch Allyn Connex Central Station2022-10-28
• K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option2019-09-10

Death

16

Malfunction

963

Total

979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1564-2025 — Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12) ) Product Code/Part # 67NXXX-B; 13) ) Product Code/Part # 68MCTP-B; 14) ) Product Code/Part # 68MCTP-B-ECG3A; 15) ) Product Code/Part # 68MCTX-B; 16) ) Product Code/Part # 68MCXX-B; 17) ) Product Code/Part # 68MXDX-B; 18) ) Product Code/Part # 68MXEP-B; 19) ) Product Code/Part # 68MXEX-B; 20) ) Product Code/Part # 68MXTP-B; 21) ) Product Code/Part # 68MXTP-B-ECG3A; 22) ) Product Code/Part # 68MXTX-B; 23) ) Product Code/Part # 68MXTX-BR; 24) ) Product Code/Part # 68NCEP-B; 25) ) Product Code/Part # 68NCTP-B; 26) ) Product Code/Part # 68NCTP-B-ECG3A; 27) ) Product Code/Part # 68NCTX-B; 28) ) Product Code/Part # 68NCXP-B; 29) ) Product Code/Part # 68NXEP-B; 30) ) Product Code/Part # 68NXEX-B; 31) ) Product Code/Part # 68NXTP-B; 32) ) Product Code/Part # 68NXTP-B-ECG3A; 33) ) Product Code/Part # 68NXTX-B; 34) ) Product Code/Part # 68NXTX-BR; 35) ) Product Code/Part # 68NXXX-B; 36) ) Product Code/Part # 67MCTP-B; 37) ) Product Code/Part # 67MCTP-B-ECG3A; 38) ) Product Code/Part # 67MCTX-B; 39) ) Product Code/Part # 67MXEX-B; 40) ) Product Code/Part # 67MXTP-B; 41) ) Product Code/Part # 68MXXX-B.Class II·Ongoing·Baxter Healthcare Corporation·20250321
• Z-1565-2025 — Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.Class II·Ongoing·Baxter Healthcare Corporation·20250321
• Z-2581-2023 — Welch Allyn Connex Spot MonitorClass II·Ongoing·Baxter Healthcare Corporation·20230810

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142356.