510(k) Report

510(k) · Cleared

Cleared

Egs Model 300

K790847510(k) TraditionalCleared May 25, 197921-day reviewClass II21 CFR 890.5850

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

Alfred V. Greco · IPF Stimulator, Muscle, Powered

Cleared on May 25, 1979 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 25, 1979
Review
21 days
Class
Class II
Product code
IPF
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared19801990200020102020
  1. This deviceK790847 Egs Model 300Alfred V. Greco · 1979
  2. Descendant · cites it directly · 0 of its ownK955666 EGS4000S&P Electrical Industries, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K955666EGS4000S&P Electrical Industries, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K790847Egs Model 300Alfred V. Greco1979—
+1K955666EGS4000S&P Electrical Industries, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K790847, 1979–1997Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IPF? 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 IPF device

  1. #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K955666EGS4000S&P Electrical Industries, Inc.19970

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, K955666 (S&P Electrical Industries, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPF

3in 2025

2007: 82008: 62009: 72010: 42011: 42012: 42013: 102014: 42015: 32016: 72017: 52018: 52019: 42020: 92021: 152022: 72023: 92024: 72025: 32026 (partial year): 3
2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007: 143 days median2008: 140 days median2009: 216 days median2010: 121 days median2011: 275 days median2012: 269 days median2013: 180 days median2014: 264 days median2015: 43 days median2016: 113 days median2017: 110 days median2018: 73 days median2019: 133 days median2020: 121 days median2021: 98 days median2022: 108 days median2023: 255 days median2024: 201 days median2025: 257 days median2026 (partial year): 206 days median
2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2008: 12011: 12012: 32023: 1
2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IPF

8in 2025

2007: 112008: 2132009: 1502010: 142011: 252012: 162013: 62014: 192015: 112016: 82017: 22018: 32019: 102020: 132021: 32022: 42023: 82024: 52025: 8
2007high 213 (2008) · low 2 (2017)2025

MAUDE reports naming product code IPF, 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
20078143011
200861401213
200972160150
20104121014
20114275125
20124269316
20131018006
20144264019
2015343011
2016711308
2017511002
201857303
20194133010
20209121013
2021159803
2022710804
2023925518
2024720105
2025325708
202632060—
Cite this page

510(k) Report. “K790847: Egs Model 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K790847

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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