510(k) Report

510(k) · Cleared

Cleared

Salonmay Bustline Increaser

K770082510(k) TraditionalCleared Mar 16, 197761-day reviewClass I21 CFR 890.5660

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

Gamma Enterprises, Inc. · MWZ Expander, Breast, External

Cleared on Mar 16, 1977 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 16, 1977
Review
61 days
Class
Class I
Product code
MWZ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K770082Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MWZ? 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
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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All MWZ devices

MWZ Expander, Breast, External: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWZ

FDA has decided no MWZ device since 2007.

Median 510(k) review, days · MWZ

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

Recalls per year · MWZ

No recall names MWZ since 2007.

Adverse event reports per year · MWZ

No MAUDE report names MWZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Gamma Enterprises, Inc.

23 FDA decisions under this applicant name. See the company

  • K790578Gamma Smac ReagentsGamma Enterprises, Inc. · 1979
  • K780507Serum Glutamic-Pyruvic TransaminaseGamma Enterprises, Inc. · 1978
  • K780505Serum Glutamic-Oxaloacetic-TransaminaseGamma Enterprises, Inc. · 1978
  • K780506Carbon Dioxide ReagentsGamma Enterprises, Inc. · 1978
  • K780504Creatine Phosphokinase (CPK)Gamma Enterprises, Inc. · 1978

https://510kreport.com/device/K770082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K770082: Salonmay Bustline Increaser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770082

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