510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Runyon Large Volume Paracentesis Kit

K970187510(k) TraditionalCleared Feb 14, 199728-day reviewClass II21 CFR 878.4370Recalls 1

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

Gi Supply · LRO General Surgery Tray

Cleared on Feb 14, 1997 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Feb 14, 1997
Review
28 days
Class
Class II
Product code
LRO
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970187 Runyon Large Volume Paracentesis KitGi Supply · 1997
  2. Descendant · cites it directly · 0 of its ownK221042 Renova RP Centesis PumpGi Supply, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K221042Renova RP Centesis PumpGi Supply, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970187Runyon Large Volume Paracentesis KitGi Supply1997—
+1K221042Renova RP Centesis PumpGi Supply, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K970187, 1997–2023Source: 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 LRO? 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 LRO device

  1. #1 K212258 Medline Cardiovascular Procedure Kitscore 2.5 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K221042Renova RP Centesis PumpGi Supply, Inc.20230

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 28, 2016Class IIZ-1047-2016Nonconforming Material/ComponentCustomers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K221042 (Gi Supply, Inc., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LRO devices

LRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRO

1in 2022

2021: 12022: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRO

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

Recalls per year · LRO

14in 2025

2007: 12009: 22010: 12011: 112012: 42013: 11, 11 Class I2014: 59, 58 Class I2015: 52016: 42017: 292018: 312019: 42020: 32021: 32022: 1922023: 18, 2 Class I2024: 60, 1 Class I2025: 14, 5 Class I2026 (partial year): 75, 16 Class I
2007high 192 (2022) · low 0 (2008)2026

Class I (93 since 2007) Class II/III not classified

Adverse event reports per year · LRO

5,488in 2025

2007: 82008: 82009: 52010: 232011: 172012: 642013: 252014: 592015: 6282016: 8052017: 5232018: 3842019: 4062020: 7672021: 9202022: 1,1342023: 1,9132024: 3,0312025: 5,488
2007high 5,488 (2025) · low 5 (2009)2025

MAUDE reports naming product code LRO, 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—18
20080—08
20090—25
20100—123
20110—1117
20120—464
20130—11 (11)25
20140—59 (58)59
20150—5628
20160—4805
20170—29523
20180—31384
20190—4406
20200—3767
20211—3920
20221—1921,134
20230—18 (2)1,913
20240—60 (1)3,031
20250—14 (5)5,488
20260—75 (16)—

More from Gi Supply

8 FDA decisions under this applicant name. See the company

  • K191923EverLift Submucosal Lifting AgentGi Supply · 2020
  • K031360GI Supply Biliary StentGi Supply · 2003
  • K012411HP-ONEGi Supply · 2001
  • K970186GI Supply Paracentesis PumpGi Supply · 1997
  • K944903HP-FastGi Supply · 1995

Recent decisions in LRO

The LRO category page

  • K213481Medline General Surgery TrayMedline Industries, Inc. · 202211 Class I recalls
  • K212258Medline Cardiovascular Procedure KitMedline Industries, Inc. · 2021
  • K041080Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L. · 2004
  • K030721Quick-Tap Paracentesis Tray, Kit & NeedleBallard Medical Products · 2003
  • K023276Amsino Tracheostomy Care TrayAmsino International, Inc. · 2002

https://510kreport.com/device/K970187 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970187: Runyon Large Volume Paracentesis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970187

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