510(k) Report

FDA applicant

Capsule Technologie

Andover, MA9 decisions2001–20212 recalls

FDA records 9 decisions for Capsule Technologie (Andover, MA) from 2001 to 2021: 9 510(k) clearances. All are in product code MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Capsule Technologie Sas”.

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 Capsule Technologie’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015: 12017: 12018: 12019: 12020: 12021: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)9decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 205 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 7 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.

  • K032142DatacaptorCapsule Technologie · 20035cite it
  • K013019DatacaptorCapsule Technologie · 20013cite it
  • K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals…Capsule Technologie Sas · 20172cite it
  • K020197Modification to DatacaptorCapsule Technologie · 20022cite it
  • K183638SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie · 20191cites it
  • K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas · 20201cites it

What has FDA decided for it lately?

  • K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas · 2021
  • K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas · 2020
  • K183638SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie · 2019
  • K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie · 2018
  • K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals…Capsule Technologie Sas · 2017
  • K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas · 2015
  • K032142DatacaptorCapsule Technologie · 20032 recalls
  • K020197Modification to DatacaptorCapsule Technologie · 20022 recalls

All 5 as Capsule Technologie →All 4 as Capsule Technologie Sas →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K013019Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System…Aug 10, 2012Class II
  • K013019Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. Catalog…Aug 25, 2010

Other applicant names beginning “Capsule”

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

Capsule Surveillance Technologies, Sas /Capsule Tech… 1Capsule Tech, Inc. 1