510(k) Report

510(k) · Cleared

Cleared

Monitoring System, Model Argus PB-2200

K033738510(k) TraditionalCleared Aug 24, 2004270-day reviewClass II21 CFR 870.1110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Schiller AG · DSK Computer, Blood-Pressure

Cleared on Aug 24, 2004 as substantially equivalent to K012226 (Schiller AG, 2002) after a 270-day review. Its family tree reaches back 2 generations to 1997.

Decided
Aug 24, 2004
Review
270 days
Class
Class II
Product code
DSK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K970879 (1997). No later device cites it as a predicate yet.

K970879 · Cardiovit CS-200 · Schiller America, Inc. · 1997K012226 · Monitoring System,Model Argus PB-1000 · Schiller AG · 2002199619982000200220042006
K012226 · Monitoring System,Model Argus PB-1000 · Schiller AG · 2002K970879 · Cardiovit CS-200 · Schiller America, Inc. · 19970
  1. Root · 2 generations backK970879 Cardiovit CS-200Schiller America, Inc. · 1997
  2. 1 generation backK012226 Monitoring System,Model Argus PB-1000Schiller AG · 2002
  3. This deviceK033738 Monitoring System, Model Argus PB-2200Schiller AG · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K970879Cardiovit CS-200Schiller America, Inc.1997—
−1K012226Monitoring System,Model Argus PB-1000Schiller AG2002—
0 (this device)K033738Monitoring System, Model Argus PB-2200Schiller AG2004—
FIG. 1 — Lineage of K033738, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DSK? 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 DSK device

  1. #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012226Monitoring System,Model Argus PB-1000
Summary page 1
…mmon Name: Monitoring System A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: ARGUS PB-i1000 System K 012226 A4 Intended Use The Monitoring System ARGUS PB-2200 is for the monitoring of vital parameters such as: Invasive Blood Pr…
Schiller AG2002—

Also cleared against K012226: 3 other devices →

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 7 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
  • None of the 2 ancestors has a recall.
  • 3 other devices also cite its predicate K012226.

How does its category compare?

All DSK devices

DSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSK

1in 2023

2007: 12008: 12015: 22016: 12023: 1
2007high 2 (2015) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSK

Too few DSK 510(k)s in any year since 2007 to give a median.

Recalls per year · DSK

No recall names DSK since 2007.

Adverse event reports per year · DSK

26in 2025

2010: 102011: 52012: 692013: 52014: 82015: 72016: 132017: 62018: 932019: 1482020: 292021: 312022: 292023: 142024: 122025: 26
2007high 148 (2019) · low 0 (2007)2025

MAUDE reports naming product code DSK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20090—00
20100—010
20110—05
20120—069
20130—05
20140—08
20152—07
20161—013
20170—06
20180—093
20190—0148
20200—029
20210—031
20220—029
20231—014
20240—012
20250—026
20260—0—

What is it indicated for?

The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as: Invasive blood pressure: systolic, diastolic and mean pressure CO2, etCO2 and CO2 ins, main and/or sidestream F102 It will extend the functionality of the existing Argus PB-1000 system (K012226). The system comprises the parameter box PB-1000 and the visualisation unit ARGUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations…

Read the full statement (170 words)

The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as:

Invasive blood pressure: systolic, diastolic and mean pressure

CO2, etCO2 and CO2 ins, main and/or sidestream

F102

It will extend the functionality of the existing Argus PB-1000 system (K012226).

The system comprises the parameter box PB-1000 and the visualisation unit ARGUS PRO. The two units are connected via a serial interface.

All vital parameters and evaluations are registered and calculated in the PB-2200. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO.

The PB-2200 is operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.

The system is intended for use in the intensive care unit, in the recovery room, in the operating theatre and during hospital internal transports.

Indications for use as stated in the FDA summary.

Also cleared against K012226

3 other devices cite the same predicate.

  • K221056Argus PB-3000Schiller AG · 20231 recall
  • K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 20131 recall
  • K053207Argus, Model LCMSchiller AG · 2006

More from Schiller AG

17 FDA decisions under this applicant name. See the company

  • K253562medilogFDSchiller AG · 2026
  • K221056Argus PB-3000Schiller AG · 20231 recall
  • K183425Cardiovit at-102 G2Schiller AG · 20201 recall
  • K170182Cardiovit FT-1Schiller AG · 2017
  • K152043Diagnostic Station DS20Schiller AG · 2016

Recent decisions in DSK

The DSK category page

  • K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
  • K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
  • K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation · 2015
  • K141615Endophys Blood Pressure MonitorEndophys, Inc. · 2015
  • K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008

https://510kreport.com/device/K033738 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033738: Monitoring System, Model Argus PB-2200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033738

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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