510(k) Report

510(k) · Cleared

Cleared

Flexicair Exlipse

K951001510(k) TraditionalCleared Jun 27, 1995116-day reviewClass II21 CFR 890.5170

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

Hill-Rom, Inc. · IOQ Bed, Flotation Therapy, Powered

Cleared on Jun 27, 1995 after a 116-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 27, 1995
Review
116 days
Class
Class II
Product code
IOQ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2013: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951001 Flexicair ExlipseHill-Rom, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK970636 Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK122473 Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed…Hill-Rom · 2013 · Recalled
  4. Descendant · cites it directly · 0 of its ownK970295 Flexicair Exlipse PlusHill-Rom, Inc. · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K970636Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc. · 1997 · cites it directly1descendant
  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 2013 · 2 generations on0descendants
  • K970295Flexicair Exlipse PlusHill-Rom, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951001Flexicair ExlipseHill-Rom, Inc.1995—
+1K970636Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc.19971
+2K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System…Hill-Rom20132
+1K970295Flexicair Exlipse PlusHill-Rom, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
201310
FIG. 1 — Lineage of K951001, 1995–2013Source: 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 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
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K970636Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc.19971
K970295Flexicair Exlipse PlusHill-Rom, 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, K970636 (Hill-Rom, Inc., 1997) has gone furthest, with 1 descendant 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 Hill-Rom, Inc.

34 FDA decisions under this applicant name. See the company

  • K260211Dashboard (P007000)Hill-Rom, Inc. · 2026
  • K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate…Hill-Rom, Inc. · 2021
  • K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals…Hill-Rom, Inc. · 2018
  • K013709Hill-Rom Primaview Monitor SystemHill-Rom, Inc. · 2001
  • K973705Contor Table SurfaceHill-Rom, Inc. · 1998

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/K951001 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951001: Flexicair Exlipse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951001

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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