510(k) Report

510(k) · Cleared

Cleared

Inamed Ruiz-Cohen Intraoperative Tissue Expander

K904265510(k) TraditionalCleared Mar 6, 1991169-day reviewClass I21 CFR 878.4800

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

Inamed Development Co. · FZW Expander, Surgical, Skin Graft

Cleared on Mar 6, 1991 after a 169-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided
Mar 6, 1991
Review
169 days
Class
Class I
Product code
FZW
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK904265 Inamed Ruiz-Cohen Intraoperative Tissue ExpanderInamed Development Co. · 1991
  2. Descendant · cites it directly · 1 of its ownK972109 Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997
  3. Descendant · 2 generations on · 0 of its ownK080158 LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997 · cites it directly1descendant
  • K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904265Inamed Ruiz-Cohen Intraoperative Tissue ExpanderInamed Development Co.1991—
+1K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations1997—
+2K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200810
FIG. 1 — Lineage of K904265, 1991–2008Source: 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 FZW? 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?

The FDA summary names no predicate by number.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations19971

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, K972109 (General Surgical Innovations, 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FZW devices

FZW Expander, Surgical, Skin Graft: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZW

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZW

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

Recalls per year · FZW

1in 2010

2008: 62010: 1
2007high 6 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FZW

433in 2025

2008: 32009: 722010: 512011: 122012: 692013: 1762014: 762015: 542016: 192017: 4462018: 4802019: 4692020: 4862021: 5542022: 5102023: 6052024: 4432025: 433
2007high 605 (2023) · low 0 (2007)2025

MAUDE reports naming product code FZW, 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—00
20081—63
20090—072
20100—151
20110—012
20120—069
20130—0176
20140—076
20150—054
20160—019
20170—0446
20180—0480
20190—0469
20200—0486
20210—0554
20220—0510
20230—0605
20240—0443
20250—0433
20260—0—

More from Inamed Development Co.

7 FDA decisions under this applicant name. See the company

  • K931548Inamed Development Aspiration TipInamed Development Co. · 1994
  • K901742Inamed Small Drain SystemInamed Development Co. · 1990
  • K901764Inamed Convertible Drain SystemInamed Development Co. · 1990
  • K894618Inamed Rhemo-D (TM) DilatorInamed Development Co. · 1990
  • K896491Inamed Closed-Wound Drain SystemInamed Development Co. · 1990

Recent decisions in FZW

The FZW category page

  • K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008
  • K984448Bircoll Balloon DissectorWells Johnson Co. · 1999
  • K972109Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997
  • K936186Aesculap Skin Graft MesherAesculap, Inc. · 1994
  • K902349Surgitek Intra-Span Intraoperative Tissue ExpanderSurgitek · 1990

https://510kreport.com/device/K904265 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904265: Inamed Ruiz-Cohen Intraoperative Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904265

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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