510(k) Report

FDA applicant

Microlife Intellectual Property GmbH

Great Neck, NY54 decisions2003–20231 recall

FDA records 54 decisions for Microlife Intellectual Property GmbH (Great Neck, NY) from 2003 to 2023: 54 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 193 days from receipt to decision, against 187 for FDA’s reviews in the same codes and years. Its devices cite 81 predicates, 45 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Microlife Intellectual Property GmbH’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2007: 12008: 32009: 32010: 42011: 32012: 22013: 12014: 12015: 32016: 12017: 32018: 22019: 32020: 32021: 22022: 12023: 3
2007high 4 (2010) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Microlife Intellectual Property GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microlife Intellectual Property GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive33decisions
  • FLLContinuous Measurement Thermometer20decisions
  • BZHMeter, Peak Flow, Spirometry1decision

How long do its 510(k) reviews take?

Since 2016, its 18 510(k)s took a median of 193 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 187 days; 8 of its 18 were faster than that.

Whose devices does it build on?

Its devices cite 81 predicates; 45 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 84 times; 45 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 20209cite it
  • K061471Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PCMicrolife Intellectual Property GmbH · 20066cite it
  • K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 20164cite it
  • K040723Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software)Microlife Intellectual Property GmbH · 20044cite it
  • K073198Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home (BP3MX1-1)Microlife Intellectual Property GmbH · 20084cite it
  • K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200).Microlife Intellectual Property GmbH · 20084cite it

What has FDA decided for it lately?

  • K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH · 2023
  • K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH · 2023
  • K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH · 2023
  • K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH · 2022
  • K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH · 2021
  • K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2021
  • K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2020
  • K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2020

All 54 as Microlife Intellectual Property GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K152770Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in…Feb 27, 2017Class II

Other applicant names beginning “Microlife”

FDA records each applicant name separately; these may or may not be the same firm.

Microlife Corp. 16Microlife Intellectual Property GmbH, Switzerland 3Microlife Intellectual Property Gmb 1Microlife Systems AG 1