510(k) Report

510(k) · Cleared

Cleared

Pollenex Digital Sphygmomanometer BP-4000

K844397510(k) TraditionalCleared Apr 18, 1985156-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

Associated Mills, Inc. · DSK Computer, Blood-Pressure

Cleared on Apr 18, 1985 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 18, 1985
Review
156 days
Class
Class II
Product code
DSK
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K844397Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

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—

More from Associated Mills, Inc.

14 FDA decisions under this applicant name. See the company

  • K901459DS60 Toothbrush SanitizerAssociated Mills, Inc. · 1990
  • K872327Whirlpool Aerator WB700, WB800, WB900, WB975Associated Mills, Inc. · 1987
  • K871661WH150 Room HumidifierAssociated Mills, Inc. · 1987
  • K862041WM10, WM20, WM30 Power MassagerAssociated Mills, Inc. · 1986
  • K862042SH20, SH30 & SH50 Ultrasonic HumidifierAssociated Mills, Inc. · 1986

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/K844397 · printed Nov 4, 2026

Cite this page

510(k) Report. “K844397: Pollenex Digital Sphygmomanometer BP-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844397

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026