510(k) · Cleared
ClearedPF 5050 Pressure Unit, Model PF 5050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimed AB · DPW Flowmeter, Blood, Cardiovascular
Cleared on Nov 6, 2001 as substantially equivalent to K951486 (Vasamedics, LLC, 1995) after a 141-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Nov 6, 2001
- Review
- 141 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951486 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951486 Model PV2000 Vascular MicrolaboratoryVasamedics, LLC · 1995
- This deviceK011899 PF 5050 Pressure Unit, Model PF 5050Perimed AB · 2001
- Descendant · cites it directly · 1 of its ownK152930 PeriFlux6000Perimed AB · 2016
- Descendant · 2 generations on · 0 of its ownK243852 Elfor-LElfi-Tech, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK102433 Moorvms-Pres Pressure Cuff ControllerMoor Instruments, Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951486 | Model PV2000 Vascular Microlaboratory | Vasamedics, LLC | 1995 | — |
| 0 (this device) | K011899 | PF 5050 Pressure Unit, Model PF 5050 | Perimed AB | 2001 | — |
| +1 | K152930 | PeriFlux6000 | Perimed AB | 2016 | — |
| +2 | K243852 | Elfor-L | Elfi-Tech, Ltd. | 2025 | — |
| +1 | K102433 | Moorvms-Pres Pressure Cuff Controller | Moor Instruments, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951486 | Model PV2000 Vascular MicrolaboratorySummary page 1…ecorder 6.3 Predicate Device Identification: _Legally marketed devices to which equivalence is being claimed 510(k) # MODEL PV2000 VASCULAR MICROLABORATORY, VASAMEDICS K951486 6.4 Device Description (for detailed description see Section 12.4): The PF 5050 Pressure Unit is a modular unit that can be ins… | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Use of the PF 5050 Pressure Unit is indicated for non-invasive
Pulse Volume waveform Recordings (PVR) on extremities of
patients with vascular diseases.
it is also intended to measure and control the pressure in a biood
pressure cuff to simplify simultaneous measurements of
perfusion and pressure when used in conjunction with a
laser Doppler perfusion monitor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011899: PF 5050 Pressure Unit, Model PF 5050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011899
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026