510(k) Report

510(k) · Cleared

Cleared

Novabed Patient Transfer System

K964246510(k) TraditionalCleared Jan 22, 199790-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 22, 1997 after a 90-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Jan 22, 1997
Review
90 days
Class
Class II
Product code
FNL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK964246 Novabed Patient Transfer SystemNova Technology Corp. · 1997
  2. Descendant · cites it directly · 0 of its ownK080506 Martin Chair, Model C4S1Martin Manufacturing Co., LLC · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080506Martin Chair, Model C4S1Martin Manufacturing Co., LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964246Novabed Patient Transfer SystemNova Technology Corp.1997—
+1K080506Martin Chair, Model C4S1Martin Manufacturing Co., LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K964246, 1997–2008Source: 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 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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Novabed Patient Transfer System
Named without a submission number
—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K080506Martin Chair, Model C4S1Martin Manufacturing Co., LLC20080

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, K080506 (Martin Manufacturing Co., LLC, 2008) has gone furthest, with 0 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)—

What is it indicated for?

The intended use of Nova Technologies, Inc.’s Novabed System is to transfer a patient from or to the bed.

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

Cite this page

510(k) Report. “K964246: Novabed Patient Transfer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964246

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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