510(k) Report

510(k) · Cleared

Cleared

Percutaneous Nephrostomy Sets (Otto)

K854906510(k) TraditionalCleared Jan 24, 19860-day reviewClass I21 CFR 878.4200

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

Angiomed U.S., Inc. · GBO Catheter, Nephrostomy, General & Plastic Surgery

Cleared on Jan 24, 1986 after a 0-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 24, 1986
Review
0 days
Class
Class I
Product code
GBO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K854906Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GBO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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 GBO devices

GBO Catheter, Nephrostomy, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBO

FDA has decided no GBO device since 2007.

Median 510(k) review, days · GBO

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

Recalls per year · GBO

1in 2019

2009: 12019: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GBO

68in 2025

2007: 142008: 112009: 52010: 82011: 62012: 42013: 62014: 202015: 472016: 382017: 4222018: 4352019: 1752020: 1272021: 1152022: 1212023: 1452024: 322025: 68
2007high 435 (2018) · low 4 (2012)2025

MAUDE reports naming product code GBO, 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—014
20080—011
20090—15
20100—08
20110—06
20120—04
20130—06
20140—020
20150—047
20160—038
20170—0422
20180—0435
20190—1175
20200—0127
20210—0115
20220—0121
20230—0145
20240—032
20250—068
20260—0—

More from Angiomed U.S., Inc.

24 FDA decisions under this applicant name. See the company

  • K874771Angiomed Introducing SetsAngiomed U.S., Inc. · 1988
  • K874585Angiomed Osty-Cut Bone Biopsy NeedleAngiomed U.S., Inc. · 1987
  • K864225Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentAngiomed U.S., Inc. · 1987
  • K863386Vesico Suprapubic Bladder Drainage & Exchange SetsAngiomed U.S., Inc. · 1986
  • K862805Angiomed Vac-U-Cut Biopsy NeedleAngiomed U.S., Inc. · 1986

Recent decisions in GBO

The GBO category page

  • K041995Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter, Nephrostomy Catheter…Uresil, LLC · 2004
  • K021632GP General Purpose Drainage Catheter; Mini-Pigtail Drainage Catheter with Locking Pigtail; GP General…Uresil, L.P. · 2002
  • K912109Uresil General Purpose Drainage CatheterUresil Corp. · 1991
  • K854911Percutaneous Nephrostomy Sets (Schuller)Angiomed U.S., Inc. · 1986
  • K854907Percutaneous Nephrostomy Sets (Gunther)Angiomed U.S., Inc. · 1986

https://510kreport.com/device/K854906 · printed Nov 4, 2026

Cite this page

510(k) Report. “K854906: Percutaneous Nephrostomy Sets (Otto).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854906

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