510(k) Report

510(k) · Cleared

Cleared

Enterprise

K935998510(k) TraditionalCleared Nov 17, 1995702-day reviewClass II21 CFR 870.1330

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

Camp Intl., Inc. · DQX Wire, Guide, Catheter

Cleared on Nov 17, 1995 after a 702-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 56 later devices descend from it.

Decided
Nov 17, 1995
Review
702 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

56 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2018: 3 descendants cleared2020: 4 descendants cleared2021: 12 descendants cleared2019: 2 descendants cleared2023: 3 descendants cleared2022: 11 descendants cleared2025: 6 descendants cleared2026: 5 descendants cleared2024: 6 descendants cleared1995200020052010201520202025
  1. This deviceK935998 EnterpriseCamp Intl., Inc. · 1995
  2. Descendant · cites it directly · 55 of its ownK013436 Normatec PCDNormatec, Inc. · 2001
  3. Descendant · 2 generations on · 52 of its ownK112890 Normatec MVPNormaTec Industries, LP · 2012
  4. Descendant · 3 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
  5. Descendant · 4 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
  6. Descendant · 4 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2001: 12012: 12016: 22018: 32019: 22020: 42021: 122022: 112023: 32024: 62025: 62026: 5
2001high 12 (2021) · low 0 (2002)2026

Most influential descendants

Showing 5 of 56 · See all
  • K013436Normatec PCDNormatec, Inc. · 2001 · cites it directly55descendants
  • K112890Normatec MVPNormaTec Industries, LP · 2012 · 2 generations on52descendants
  • K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 3 generations on51descendants
  • K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 4 generations on38descendants
  • K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 4 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935998EnterpriseCamp Intl., Inc.1995—
+1K013436Normatec PCDNormatec, Inc.2001—
+2K112890Normatec MVPNormaTec Industries, LP2012—
+3K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP2016—
+4K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC2018—
+4K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201210
201620
201830
201920
202040
2021120
2022110
202330
202460
202560
202650
FIG. 1 — Lineage of K935998, 1995–2026Source: 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 DQX? 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K013436Normatec PCDNormatec, Inc.200155

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, K013436 (Normatec, Inc., 2001) has gone furthest, with 55 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

More from Camp Intl., Inc.

2 FDA decisions under this applicant name. See the company

  • K940238Tumble Forms Junior TristanderCamp Intl., Inc. · 1994

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The DQX category page

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https://510kreport.com/device/K935998 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935998: Enterprise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935998

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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