510(k) Report

510(k) · Cleared

Cleared

Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor

K895700510(k) TraditionalCleared Apr 2, 1990192-day reviewClass II21 CFR 884.4340

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

Hollister, Inc. · HDB Extractor, Vacuum, Fetal

Cleared on Apr 2, 1990 after a 192-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
Apr 2, 1990
Review
192 days
Class
Class II
Product code
HDB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared1998: 1 descendant cleared1990200020102020
  1. This deviceK895700 Ameda/Egnell Dolphin Dispo-Soft Vacuum ExtractorHollister, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK041579 Medela Single Use Silc Cup, Model 077.0791Medela AG · 2005
  3. Descendant · cites it directly · 0 of its ownK980976 Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHollister, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K041579Medela Single Use Silc Cup, Model 077.0791Medela AG · 2005 · cites it directly0descendants
  • K980976Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHollister, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895700Ameda/Egnell Dolphin Dispo-Soft Vacuum ExtractorHollister, Inc.1990—
+1K041579Medela Single Use Silc Cup, Model 077.0791Medela AG2005—
+1K980976Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHollister, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200510
FIG. 1 — Lineage of K895700, 1990–2005Source: 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 HDB? 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 HDB device

  1. #1 K250298 Kiwi® Complete Vacuum Delivery System…score 10.7 · 3 generations · 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)

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

NumberDeviceApplicantDecidedDescendants
K041579Medela Single Use Silc Cup, Model 077.0791Medela AG20050
K980976Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHollister, Inc.19980

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, K041579 (Medela AG, 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HDB devices

HDB Extractor, Vacuum, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HDB

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HDB

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

Recalls per year · HDB

3in 2008

2008: 32026 (partial year): 1
2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HDB

17in 2025

2007: 252008: 352009: 122010: 132011: 82012: 92013: 72014: 112015: 132016: 152017: 162018: 252019: 312020: 242021: 212022: 122023: 232024: 242025: 17
2007high 35 (2008) · low 7 (2013)2025

MAUDE reports naming product code HDB, 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—025
20080—335
20090—012
20100—013
20110—08
20120—09
20130—07
20140—011
20150—013
20160—015
20170—016
20180—025
20190—031
20200—024
20210—021
20220—012
20230—023
20240—024
20251—017
20260—1—

More from Hollister, Inc.

85 FDA decisions under this applicant name. See the company

  • K123804Instaflo Bowel Catheter System KitHollister, Inc. · 2013
  • K100273Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144…Hollister, Inc. · 2009
  • K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009
  • K050483Evadri Bladder Control SystemsHollister, Inc. · 2005

Recent decisions in HDB

The HDB category page

  • K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System…Clinical Innovations, LLC · 2025
  • K041579Medela Single Use Silc Cup, Model 077.0791Medela AG · 2005
  • K043614Vaculink, Model VCL 3000Medevco, Inc. · 2005
  • K021193Fortune Silicone Vacuum Suction, Model #1300Fortune Medical Instrument Corp. · 2003
  • K020447Mityvac Merlin, Model 10027Prism Enterprises, Inc. · 2002

https://510kreport.com/device/K895700 · printed Nov 5, 2026

Cite this page

510(k) Report. “K895700: Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895700

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