510(k) · Cleared

Cleared

Spacemaker Surgicalballoon Dissector/Expander

K972109510(k) TraditionalCleared Nov 14, 1997162-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

General Surgical Innovations · FZW Expander, Surgical, Skin Graft

Cleared on Nov 14, 1997 as substantially equivalent to K951878 (General Surgical Innovations, 1995) and 3 other predicates after a 162-day review. Its family tree reaches back 1 generation to 1984. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Nov 14, 1997
Review: 162 days
Class: Class I
Product code: FZW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K843704 (1984). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK843704 Mcghan Tissue ExpanderMcghan Medical Corp. · 1984
This deviceK972109 Spacemaker Surgicalballoon Dissector/ExpanderGeneral Surgical Innovations · 1997
Descendant · cites it directly · 0 of its ownK080158 LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008

Class I recalls in this family

K862203 Mcghan Magna-Site (TM) Tissue Expanderdirect predicate · 1986

Most influential descendants

Showing 1 of 1 · See all

K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K843704	Mcghan Tissue Expander	Mcghan Medical Corp.	1984	—
0 (this device)	K972109	Spacemaker Surgicalballoon Dissector/Expander	General Surgical Innovations	1997	—
+1	K080158	LB Medical Inflatable Tissue Elevator/Expander System	Lb Medical LLC	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	1
1991	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K972109, 1984–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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? (4)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951878	Spacemaker, II Surgical Balloon Dissector with and Without a Cannula Summary page 5 …ax 2.Date Summary Prepared 6/4/97 3.Trade Name Spacemaker® Surgical Balloon Dissector/Expander 4.Common Name Surgical Balloon Dissector/Expander 5.Predicate Devices K951878 Spacemaker® and Spacemaker® \|\| Surgical Balloon Dissector with and without Cannula K904265 Inamed Ruiz-Cohen Intraoperative Expa…	General Surgical Innovations	1995	—
*	K904265	Inamed Ruiz-Cohen Intraoperative Tissue Expander Summary page 5 …nder 4.Common Name Surgical Balloon Dissector/Expander 5.Predicate Devices K951878 Spacemaker® and Spacemaker® \|\| Surgical Balloon Dissector with and without Cannula K904265 Inamed Ruiz-Cohen Intraoperative Expander K862203 McGhan Magna-Site™ Tissue Expander K843704 McGhan Tissue Expander 6.Device D…	Inamed Development Co.	1991	—
*	K862203	Mcghan Magna-Site (TM) Tissue Expander Summary page 5 …nder 5.Predicate Devices K951878 Spacemaker® and Spacemaker® \|\| Surgical Balloon Dissector with and without Cannula K904265 Inamed Ruiz-Cohen Intraoperative Expander K862203 McGhan Magna-Site™ Tissue Expander K843704 McGhan Tissue Expander 6.Device Description The Spacemaker® Surgical Balloon Dissect…	Mcghan Medical Corp.	1986	Class I
*	K843704	Mcghan Tissue Expander Summary page 5 …r® and Spacemaker® \|\| Surgical Balloon Dissector with and without Cannula K904265 Inamed Ruiz-Cohen Intraoperative Expander K862203 McGhan Magna-Site™ Tissue Expander K843704 McGhan Tissue Expander 6.Device Description The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld, manually m…	Mcghan Medical Corp.	1984	—

Also cleared against K951878: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K080158	LB Medical Inflatable Tissue Elevator/Expander System	Lb Medical LLC	2008	0

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.

K862203Mcghan Magna-Site (TM) Tissue ExpanderMcghan Medical Corp. · 1986 · Direct predicate · ◆ in the 1986 ancestors bar of FIG. 13 Class I recalls

What does this lineage say?

1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K080158 (Lb Medical LLC, 2008) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K951878.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	1	—	6	3
2009	0	—	0	72
2010	0	—	1	51
2011	0	—	0	12
2012	0	—	0	69
2013	0	—	0	176
2014	0	—	0	76
2015	0	—	0	54
2016	0	—	0	19
2017	0	—	0	446
2018	0	—	0	480
2019	0	—	0	469
2020	0	—	0	486
2021	0	—	0	554
2022	0	—	0	510
2023	0	—	0	605
2024	0	—	0	443
2025	0	—	0	433
2026	0	—	0	—

What is it indicated for?

The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.

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

https://510kreport.com/device/K972109 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972109: Spacemaker Surgicalballoon Dissector/Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972109

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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