510(k) Report

510(k) · Cleared

Cleared

Accuset Sensor, Model 2000

K001386510(k) TraditionalCleared Jul 17, 200076-day reviewClass II21 CFR 876.1620

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

Pelvicare, Inc. · FEN Device, Cystometric, Hydraulic

Cleared on Jul 17, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 17, 2000
Review
76 days
Class
Class II
Product code
FEN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K001386Source: 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 FEN? 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 FEN device

  1. #1 K212830 CT3000Proscore 2.9 · 2 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 FEN devices

FEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEN

1in 2021

2008: 22021: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEN

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

Recalls per year · FEN

No recall names FEN since 2007.

Adverse event reports per year · FEN

3in 2024

2009: 12012: 12013: 102014: 112015: 332016: 102017: 32018: 22019: 62021: 12022: 32023: 32024: 3
2007high 33 (2015) · low 0 (2007)2025

MAUDE reports naming product code FEN, 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
20070—00
20082—00
20090—01
20100—00
20110—00
20120—01
20130—010
20140—011
20150—033
20160—010
20170—03
20180—02
20190—06
20200—00
20211—01
20220—03
20230—03
20240—03
20250—00
20260—0—

Recent decisions in FEN

The FEN category page

  • K212830CT3000ProSrs Medical · 2021
  • K082701Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
  • K073552Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
  • K992715Neuro Urodynamic Suite, Model 9032E0101Medtronic Functional Diagnostics A/S · 2000
  • K983325IN-Probe II Urodynamic SystemInfluence, Inc. · 1998

https://510kreport.com/device/K001386 · printed Nov 4, 2026

Cite this page

510(k) Report. “K001386: Accuset Sensor, Model 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001386

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