510(k) Report

510(k) · Cleared

Cleared

Veresure Bell

K061387510(k) TraditionalCleared Jul 21, 200664-day reviewClass II21 CFR 884.1730

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

Veresure, Inc. · HIF Insufflator, Laparoscopic

Cleared on Jul 21, 2006 as substantially equivalent to K003703 (Taut, Inc., 2001) and 2 other predicates after a 64-day review. Its family tree reaches back 1 generation to 1985. 5 later devices descend from it.

Decided
Jul 21, 2006
Review
64 days
Class
Class II
Product code
HIF
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K852726 (1985). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor2007: 1 descendant cleared2008: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant clearedK852726 · Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420 · The Huxley Instrument Corp. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants K852726 · Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420 · The Huxley Instrument Corp. · 19850
  1. Root · 1 generation backK852726 Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420The Huxley Instrument Corp. · 1985
  2. This deviceK061387 Veresure BellVeresure, Inc. · 2006
  3. Descendant · cites it directly · 4 of its ownK070651 Aragon Surgical LapcapAragon Surgical, Inc. · 2007
  4. Descendant · 2 generations on · 1 of its ownK233020 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024
  5. Descendant · 2 generations on · 1 of its ownK073452 Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008
  6. Descendant · 3 generations on · 0 of its ownK242536 TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group · 2024
  7. Descendant · 3 generations on · 0 of its ownK212786 LevaLap Laparoscopic Access DeviceCore Access Surgical Technologies, Inc. · 2022

Most influential descendants

Showing 5 of 5 · See all
  • K070651Aragon Surgical LapcapAragon Surgical, Inc. · 2007 · cites it directly4descendants
  • K233020TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC · 2024 · 2 generations on1descendant
  • K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc. · 2008 · 2 generations on1descendant
  • K242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group · 2024 · 3 generations on0descendants
  • K212786LevaLap Laparoscopic Access DeviceCore Access Surgical Technologies, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K852726Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420The Huxley Instrument Corp.1985—
0 (this device)K061387Veresure BellVeresure, Inc.2006—
+1K070651Aragon Surgical LapcapAragon Surgical, Inc.2007—
+2K233020TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group Research & Development, Co., LLC2024—
+2K073452Modification to: Aragon Surgical LapcapAragon Surgical, Inc.2008—
+3K242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group2024—
+3K212786LevaLap Laparoscopic Access DeviceCore Access Surgical Technologies, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
202210
202420
FIG. 1 — Lineage of K061387, 1985–2024Source: 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.

Planning a device in HIF? 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 HIF device

  1. #1 K250388 Endoflator +score 15.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K003703Taut-Insufflation Needle
Summary page 1
…c laparoscopic procedures. Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the Taut insufflation Needle (K003703), the EndoPath Ultra Veress Needle (K983925), and the Allis Tissue Forceps (K852726). Test Results: Results of animal and clinic…
Taut, Inc.2001—
*K983925Endopath Ultra Veress Needle
Summary page 1
…e: The subject device is substantially equivalent in intended use and/or method of operation to the Taut insufflation Needle (K003703), the EndoPath Ultra Veress Needle (K983925), and the Allis Tissue Forceps (K852726). Test Results: Results of animal and clinical testing demonstrate that the VereSure Bel…
Ethicon Endo-Surgery, Inc.1999—
*K852726Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420
Summary page 1
…quivalent in intended use and/or method of operation to the Taut insufflation Needle (K003703), the EndoPath Ultra Veress Needle (K983925), and the Allis Tissue Forceps (K852726). Test Results: Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended…
The Huxley Instrument Corp.1985—

Also cleared against K003703: 1 other device →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K070651Aragon Surgical LapcapAragon Surgical, Inc.20074

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K070651 (Aragon Surgical, Inc., 2007) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K003703.

How does its category compare?

All HIF devices

HIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIF

3in 2025

2007: 42008: 22009: 42010: 22011: 52012: 52013: 22014: 22015: 22016: 32017: 52018: 32019: 22020: 42021: 12022: 12023: 72024: 42025: 32026 (partial year): 3
2007high 7 (2023) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIF

210in 2025

2007: 140 days median2009: 191 days median2011: 128 days median2012: 138 days median2016: 88 days median2017: 242 days median2018: 207 days median2020: 64 days median2023: 134 days median2024: 170 days median2025: 210 days median2026 (partial year): 265 days median
2007high 265 (2026) · low 64 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HIF

12so far in 2026, the most since 2007

2008: 12016: 12018: 12023: 1, 1 Class I2026 (partial year): 12
2007high 12 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HIF

1,507in 2025

2007: 82008: 142009: 212010: 412011: 442012: 382013: 402014: 432015: 302016: 722017: 682018: 972019: 1282020: 3602021: 6542022: 6672023: 8902024: 1,4832025: 1,507
2007high 1,507 (2025) · low 8 (2007)2025

MAUDE reports naming product code HIF, 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
2007414008
20082—114
20094191021
20102—041
20115128044
20125138038
20132—040
20142—043
20152—030
2016388172
20175242068
20183207197
20192—0128
20204640360
20211—0654
20221—0667
202371341 (1)890
2024417001,483
2025321001,507
2026326512—

What is it indicated for?

The VereSure Bell is intended for use in the penj-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K003703

1 other device cites the same predicate.

  • K070651Aragon Surgical LapcapAragon Surgical, Inc. · 2007

Recent decisions in HIF

The HIF category page

  • K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG · 2026
  • K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology, Ltd. · 2026
  • K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc. · 2026
  • K250388Endoflator +Karl Storz SE & CO. KG · 2025
  • K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc. · 2025

https://510kreport.com/device/K061387 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061387: Veresure Bell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061387

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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