510(k) Report

510(k) · Cleared

Cleared

Reavillmed Pressure Monitoring System and Picc

K101189510(k) TraditionalCleared Dec 22, 2010238-day reviewClass II21 CFR 870.2850

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

Reavillmed · DRS Transducer, Blood-Pressure, Extravascular

Cleared on Dec 22, 2010 as substantially equivalent to K842352 (Utah Medical Products, Inc., 1985) and 3 other predicates after a 238-day review. Its family tree reaches back 3 generations to 2000.

Decided
Dec 22, 2010
Review
238 days
Class
Class II
Product code
DRS
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K001901 (2000). 6 ancestors in all, the oldest K842352 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1985: 2 other ancestorsK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled0
  1. Root · 3 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 2 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 1 generation backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. This deviceK101189 Reavillmed Pressure Monitoring System and PiccReavillmed · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−2K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−1K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
0 (this device)K101189Reavillmed Pressure Monitoring System and PiccReavillmed2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198520
199410
FIG. 1 — Lineage of K101189, 2000–2010Source: 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 DRS? 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 DRS device

  1. #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.4 · 29 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K842352Pressure Monitoring Kit
Summary page 1
…President, Vantage Consulting International, Ltd. Date Prepared: December 1, 20 10 Predicate Devices: Utah Pressure Monitoring Device (K842352) Utah Disposable Pressure Transducer (K84 1788) Bard POLY P…
Utah Medical Products, Inc.1985—
*K841788Utah Disposable Pressure Transducer
Summary page 1
…December 1, 20 10 Predicate Devices: Utah Pressure Monitoring Device (K842352) Utah Disposable Pressure Transducer (K84 1788) Bard POLY PER-Q-CATH P1CC CATHETERS; POLY RADPICC (K031 129)…
Utah Medical Products, Inc.1985—
*K031129Poly Per-Q-Cath Picc Catheters; Poly Radpicc
Summary page 1
…) Utah Disposable Pressure Transducer (K84 1788) Bard POLY PER-Q-CATH P1CC CATHETERS; POLY RADPICC (K031 129) UMBILI-CATH-P (K94087 1) Device Description: The ReavilIMED pressure monitoring device is…
C.R. Bard, Inc.2003—
*K940871Umbili-Cath-P
Summary page 1
…e Transducer (K84 1788) Bard POLY PER-Q-CATH P1CC CATHETERS; POLY RADPICC (K031 129) UMBILI-CATH-P (K94087 1) Device Description: The ReavilIMED pressure monitoring device is a combination product consisting of the following components…
Gesco Intl., Inc.1994—

Also cleared against K842352: 1 other device →

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 10 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K842352.

How does its category compare?

All DRS devices

DRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DRS

1in 2025

2007: 12009: 22010: 22011: 32012: 12013: 12014: 12015: 12016: 32017: 22023: 12025: 12026 (partial year): 1
2007high 3 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRS

186in 2016

2011: 135 days median2016: 186 days median
2007high 186 (2016) · low 135 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRS

15in 2023

2016: 1622018: 112023: 152026 (partial year): 2, 2 Class I
2007high 162 (2016) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DRS

187in 2025

2007: 3972008: 5312009: 3442010: 1152011: 632012: 432013: 392014: 232015: 602016: 892017: 922018: 822019: 842020: 412021: 932022: 952023: 1472024: 2052025: 187
2007high 531 (2008) · low 23 (2014)2025

MAUDE reports naming product code DRS, 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—0397
20080—0531
20092—0344
20102—0115
20113135063
20121—043
20131—039
20141—023
20151—060
2016318616289
20172—092
20180—1182
20190—084
20200—041
20210—093
20220—095
20231—15147
20240—0205
20251—0187
20261—2 (2)—

What is it indicated for?

The ReaviHIMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.

Indications for use as stated in the FDA summary.

Also cleared against K842352

1 other device cites the same predicate.

  • K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc. · 20001 recall

Recent decisions in DRS

The DRS category page

  • K254074TruPressProcerus Enterprises · 2026
  • K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC · 2025
  • K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
  • K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling…Smiths Medical Asd, Inc. · 2017
  • K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling…Smiths Medical Asd, Inc. · 2017

https://510kreport.com/device/K101189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101189: Reavillmed Pressure Monitoring System and Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101189

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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