510(k) Report

510(k) · Cleared

Cleared

(Roth)Spiral Rotating Prostatic Biopsy Needle

K863385510(k) TraditionalCleared Nov 4, 198662-day reviewClass I21 CFR 890.3920

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

Cook Urological, Inc. · KNN Components, Wheelchair

Cleared on Nov 4, 1986 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 4, 1986
Review
62 days
Class
Class I
Product code
KNN
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK863385 (Roth)Spiral Rotating Prostatic Biopsy NeedleCook Urological, Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK041544 Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc. · 2004
  3. Descendant · 2 generations on · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005

Most influential descendants

Showing 2 of 2 · See all
  • K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc. · 2004 · cites it directly1descendant
  • K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863385(Roth)Spiral Rotating Prostatic Biopsy NeedleCook Urological, Inc.1986—
+1K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc.2004—
+2K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
FIG. 1 — Lineage of K863385, 1986–2005Source: FDA 510(k) summaries, read by 510(k) Report · 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 KNN? 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 KNN device

  1. #1 K211919 KISS Dynamic Back Support, KISS Dynamic Solid…score 3.0 · 1 generation · 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041544Cook Sidearm Core Tissue Biopsy DeviceUrological, Inc.20041

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?

  • Of its descendants, K041544 (Urological, Inc., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KNN devices

KNN Components, Wheelchair: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNN

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNN

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

Recalls per year · KNN

1in 2023

2012: 12023: 12026 (partial year): 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KNN

10in 2025

2007: 32008: 12009: 12010: 12011: 12012: 282013: 772014: 642015: 42016: 22017: 32018: 42019: 22020: 12021: 162022: 32023: 22024: 42025: 10
2007high 77 (2013) · low 1 (2008)2025

MAUDE reports naming product code KNN, 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—03
20080—01
20090—01
20100—01
20110—01
20120—128
20130—077
20140—064
20150—04
20160—02
20170—03
20180—04
20190—02
20200—01
20210—016
20221—03
20230—12
20240—04
20250—010
20260—1—

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in KNN

The KNN category page

  • K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC · 2022
  • K942310Dynasty GC 12550 (Gell/Cell)Foley & Lardner · 1994
  • K942308Dynasty GC 12400 (Gell/Cell)Foley & Lardner · 1994
  • K942309Dynasty U1-31 (Gell/Cell)Foley & Lardner · 1994
  • K942311Dynasty U1-33 AgmFoley & Lardner · 1994

https://510kreport.com/device/K863385 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863385: (Roth)Spiral Rotating Prostatic Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863385

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026