510(k) Report

510(k) · Cleared

Recalled · 2010

Flexicair

K863047510(k) TraditionalCleared Sep 5, 198624-day reviewClass II21 CFR 890.5170Recalls 5

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

Ssi Medical Services, Inc. · IOQ Bed, Flotation Therapy, Powered

Cleared on Sep 5, 1986 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 5 times.

Decided
Sep 5, 1986
Review
24 days
Class
Class II
Product code
IOQ
Recalls
5
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK863047 FlexicairSsi Medical Services, Inc. · 1986
  2. Descendant · cites it directly · 0 of its ownK964873 Silkair Low Airloss TherapyHill-Rom, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K964873Silkair Low Airloss TherapyHill-Rom, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863047FlexicairSsi Medical Services, Inc.1986—
+1K964873Silkair Low Airloss TherapyHill-Rom, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K863047, 1986–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 IOQ? 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?

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
K964873Silkair Low Airloss TherapyHill-Rom, Inc.19970

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 6, 2010Not classifiedZ-1253-2011OtherDue to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
Dec 6, 2010Not classifiedZ-1254-2011OtherDue to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
May 12, 2009Not classifiedZ-1875-2009Equipment maintenanceThe devices may emit smoke from the blower box assembly.
May 12, 2009Not classifiedZ-1874-2009Equipment maintenanceThe devices may emit smoke from the blower box assembly.
Aug 27, 2003Not classifiedZ-0058-04OtherReports of patient entrapment between mattress and side-rails.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K964873 (Hill-Rom, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IOQ devices

IOQ Bed, Flotation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOQ

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOQ

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

Recalls per year · IOQ

1in 2023

2008: 12009: 42010: 22012: 12013: 12022: 22023: 12026 (partial year): 3
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · IOQ

142in 2025

2007: 72008: 102009: 352010: 282011: 152012: 92013: 152014: 352015: 282016: 422017: 222018: 202019: 42020: 92021: 562022: 222023: 1112024: 3922025: 142
2007high 392 (2024) · low 4 (2019)2025

MAUDE reports naming product code IOQ, 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—07
20080—110
20090—435
20100—228
20110—015
20120—19
20131—115
20140—035
20151—028
20160—042
20170—022
20180—020
20190—04
20200—09
20210—056
20220—222
20230—1111
20240—0392
20250—0142
20260—3—

More from Ssi Medical Services, Inc.

6 FDA decisions under this applicant name. See the company

  • K943385Clinitron ElexisSsi Medical Services, Inc. · 1995
  • K942184Clinitron at Home Air Fluided TherapySsi Medical Services, Inc. · 19952 recalls
  • K914351Clinitron C-10Ssi Medical Services, Inc. · 1992
  • K890523SupercairSsi Medical Services, Inc. · 1989
  • K882161Acucair Cushion Continuous Airflow SystemSsi Medical Services, Inc. · 1988

Recent decisions in IOQ

The IOQ category page

  • K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015
  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 20132 recalls
  • K973624Nurse's Aid Patient Rotation SystemAir Med Assist Products · 1998
  • K970363Hydrotec Low Air Loss Therapy BedApex Metal, Inc. · 1997
  • K970364AIRTEC2 Low Air Loss Therapy BedApex Metal, Inc. · 1997

https://510kreport.com/device/K863047 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863047: Flexicair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863047

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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