510(k) Report

510(k) · Cleared

Cleared

Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts)

K960400510(k) TraditionalCleared Mar 12, 199643-day reviewClass I21 CFR 876.5090

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

Snowden-Pencer · FBM Cannula And Trocar, Suprapubic, Non-Disposable

Cleared on Mar 12, 1996 as substantially equivalent to K930666 (Snowden-Pencer, 1994) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1994. 1 of the 276 devices in its family, counting itself, has a Class I recall. 273 later devices descend from it.

Decided
Mar 12, 1996
Review
43 days
Class
Class I
Product code
FBM
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K930667 (1994). 2 ancestors in all. 273 later devices descend from it, 4 citing it directly. 1 of the 276 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2002: 5 descendants cleared1998: 1 descendant cleared2000: 1 descendant cleared1997: 1 descendant cleared2006: 3 descendants cleared2004: 4 descendants cleared2009: 3 descendants cleared2001: 1 descendant cleared2008: 6 descendants cleared2011: 8 descendants cleared2005: 5 descendants cleared2014: 12 descendants cleared2010: 1 descendant cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 7 descendants cleared2012: 4 descendants cleared2019: 12 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 6 descendants cleared2026: 23 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall1K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 21 descendants3 generations forward: 39 descendants4 generations forward: 41 descendants, 1 with a Class I recall15 generations forward: 30 descendants6 generations forward: 25 descendants7 generations forward: 33 descendants8 generations forward: 27 descendants9 generations forward: 21 descendants10 generations forward: 21 descendants11 generations forward: 9 descendants12 generations forward: 2 descendants K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled0+5+10
  1. Root · 1 generation backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. This deviceK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. Descendant · cites it directly · 269 of its ownK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. Descendant · 2 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  5. Descendant · 2 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  6. Descendant · 2 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  7. Descendant · 2 generations on · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002

Showing 5 of 273 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12000: 12001: 12002: 52004: 42005: 52006: 32008: 62009: 32010: 12011: 82012: 42013: 72014: 122015: 62016: 112017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 312026: 23
1997high 31 (2025) · low 0 (1999)2026

Class I recalls in this family

  • K223095 Senhance Surgical System4 generations on · 2023

Most influential descendants

Showing 5 of 273 · See all
  • K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Intuitive Surgical, Inc. · 2000 · cites it directly269descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 2 generations on258descendants
  • K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · 2 generations on254descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
0 (this device)K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
+1K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
+2K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+2K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+2K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
+2K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200010
200110
200250
200440
200550
200630
200860
200930
201010
201180
201240
201370
2014120
201560
2016110
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K960400, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K930666Reusable Laparoscopic Instruments W/ Electrocautery
Summary page 1
…ssories for Minimally Invasive Cardiovascular Surgery Classification Name - Endoscope and Accessories (per 21 CFR 876.1500) Equivalent Device - Snowden-Pencer 510(k) # K930666 - Reusable Laparoscopic/Endoscopic Surgical Instruments with Electrosurgical Connections and Accessories and Snowden-Pencer 510(k…
Snowden-Pencer1994—
*K930667Reusable Laparoscopic Instruments
Summary page 1
…ce - Snowden-Pencer 510(k) # K930666 - Reusable Laparoscopic/Endoscopic Surgical Instruments with Electrosurgical Connections and Accessories and Snowden-Pencer 510(k) # K930667 -- Reusable Laparoscopic/Endoscopic Surgical Instruments for General Surgery, and Plastic and Reconstructive Surgery, Including A…
Snowden-Pencer199415

What descends from it? (273)

See all 273

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Intuitive Surgical, Inc.2000269
K022989Radlite Tissue Retractor SystemGenzyme Biosurgery20020
K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery)19980
K972927Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on ConnectorRichard Wolf Medical Instruments Corp.19970

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K990144 (Intuitive Surgical, Inc., 2000) has gone furthest, with 269 descendants of its own.

How does its category compare?

All FBM devices

FBM Cannula And Trocar, Suprapubic, Non-Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FBM

FDA has decided no FBM device since 2007.

Median 510(k) review, days · FBM

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

Recalls per year · FBM

No recall names FBM since 2007.

Adverse event reports per year · FBM

1in 2024

2007: 12010: 22015: 12018: 22019: 12024: 1
2007high 2 (2010) · low 0 (2008)2025

MAUDE reports naming product code FBM, 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—01
20080—00
20090—00
20100—02
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—02
20190—01
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG) procedures), and saphenous vein harvesting,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Snowden-Pencer

10 FDA decisions under this applicant name. See the company

  • K930666Reusable Laparoscopic Instruments W/ ElectrocauterySnowden-Pencer · 1994
  • K930667Reusable Laparoscopic InstrumentsSnowden-Pencer · 199415 recalls
  • K924148Diamond-Sharp (R) TrocarsSnowden-Pencer · 1994
  • K924149Endo I/a ProbeSnowden-Pencer · 1993
  • K920985Snowden-Pencer Irrigation PumpSnowden-Pencer · 1992

Recent decisions in FBM

The FBM category page

  • K932021Entree Cannula Fascia AnchorsCore Dynamics, Inc. · 1994
  • K911813Entree CannulaCore Dynamics, Inc. · 1991
  • K900965GS-4550 Trocar Only, 11MMSolos Endoscopy, Inc. · 1990
  • K900962GS-4300 Cannula and Trocar, 5.5MMSolos Endoscopy, Inc. · 1990
  • K900955GS-4000 Reducer Sleeve, 11MM to 5MMSolos Endoscopy, Inc. · 1990

https://510kreport.com/device/K960400 · printed Nov 3, 2026

Cite this page

510(k) Report. “K960400: Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K960400

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026