510(k) Report

510(k) · Cleared

Cleared

Soma Safe Enclosure

K963701510(k) TraditionalCleared Jan 24, 1997130-day reviewClass II21 CFR 880.5100

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

Nova Technology Corp. · FNL Bed, Ac-Powered Adjustable Hospital

Cleared on Jan 24, 1997 after a 130-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 24, 1997
Review
130 days
Class
Class II
Product code
FNL
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2011: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963701 Soma Safe EnclosureNova Technology Corp. · 1997
  2. Descendant · cites it directly · 2 of its ownK103817 Posey BedJ. T. Posey Co. · 2011
  3. Descendant · cites it directly · 0 of its ownK113355 Posey BedJ. T. Posey Co. · 2012
  4. Descendant · cites it directly · 0 of its ownK113357 Posey BedJ. T. Posey Co. · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K103817Posey BedJ. T. Posey Co. · 2011 · cites it directly2descendants
  • K113355Posey BedJ. T. Posey Co. · 2012 · cites it directly0descendants
  • K113357Posey BedJ. T. Posey Co. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963701Soma Safe EnclosureNova Technology Corp.1997—
+1K103817Posey BedJ. T. Posey Co.2011—
+1K113355Posey BedJ. T. Posey Co.2012—
+1K113357Posey BedJ. T. Posey Co.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
FIG. 1 — Lineage of K963701, 1997–2012Source: 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 FNL? 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 FNL device

  1. #1 K202964 iBed Wireless with iBed Mobilescore 2.4 · 4 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K103817Posey BedJ. T. Posey Co.20112
K113355Posey BedJ. T. Posey Co.20120
K113357Posey BedJ. T. Posey Co.20120

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, K103817 (J. T. Posey Co., 2011) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FNL devices

FNL Bed, Ac-Powered Adjustable Hospital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FNL

1in 2021

2010: 12021: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FNL

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

Recalls per year · FNL

1in 2024

2007: 22008: 82009: 162010: 62011: 72012: 92013: 42014: 42015: 12016: 12018: 22019: 12022: 2, 1 Class I2023: 152024: 12026 (partial year): 1, 1 Class I
2007high 16 (2009) · low 0 (2017)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FNL

2,748in 2025

2007: 1332008: 4,4822009: 7,4602010: 12,4622011: 12,5992012: 14,6122013: 13,4732014: 5,8872015: 3,0362016: 2,0752017: 1,0472018: 1,2142019: 1,1132020: 1,1062021: 1,3772022: 1,1182023: 2,1852024: 2,3272025: 2,748
2007high 14,612 (2012) · low 133 (2007)2025

MAUDE reports naming product code FNL, 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—2133
20080—84,482
20090—167,460
20101—612,462
20110—712,599
20120—914,612
20130—413,473
20140—45,887
20150—13,036
20160—12,075
20170—01,047
20180—21,214
20190—11,113
20200—01,106
20211—01,377
20220—2 (1)1,118
20230—152,185
20240—12,327
20250—02,748
20260—1 (1)—

More from Nova Technology Corp.

3 FDA decisions under this applicant name. See the company

  • K964246Novabed Patient Transfer SystemNova Technology Corp. · 1997
  • K874448Nova Transfer System, Model XXXNova Technology Corp. · 1987

Recent decisions in FNL

The FNL category page

  • K202964iBed Wireless with iBed MobileStryker Corporation · 2021
  • K103536Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
  • K982783Vail 1000 Enclosed BedVail Products, Inc. · 19981 recall
  • K974296Model 720 Series Full/Semi Electric Bed 1120 Full Electric BedInvacare Corp. · 1998
  • K974254Benefit B3--- SeriesM.C. Healthcare Products, Inc. · 1997

https://510kreport.com/device/K963701 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963701: Soma Safe Enclosure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963701

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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