510(k) Report

510(k) · Cleared

Cleared

S-Scort...JR Quickdraw, Model 2400

K041154510(k) TraditionalCleared May 18, 200415-day reviewClass II21 CFR 878.4780

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

Sscor · BTA Pump, Portable, Aspiration (Manual Or Powered)

Cleared on May 18, 2004 as substantially equivalent to K952632 (Sscor, 1995) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.

Decided
May 18, 2004
Review
15 days
Class
Class II
Product code
BTA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K840110 (1984). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor2016: 1 descendant cleared2025: 1 descendant clearedK840110 · Laerdal Suction Unit · Laerdal Medical Corp. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K840110 · Laerdal Suction Unit · Laerdal Medical Corp. · 19840
  1. Root · 1 generation backK840110 Laerdal Suction UnitLaerdal Medical Corp. · 1984
  2. This deviceK041154 S-Scort...JR Quickdraw, Model 2400Sscor · 2004
  3. Descendant · cites it directly · 1 of its ownK153459 TacvacAthena Gtx · 2016
  4. Descendant · cites it directly · 0 of its ownK251101 AIRO Suction Unit (AIRO-01)Cro, LLC · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K153459TacvacAthena Gtx · 2016 · cites it directly1descendant
  • K251101AIRO Suction Unit (AIRO-01)Cro, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K840110Laerdal Suction UnitLaerdal Medical Corp.1984—
0 (this device)K041154S-Scort...JR Quickdraw, Model 2400Sscor2004—
+1K153459TacvacAthena Gtx2016—
+1K251101AIRO Suction Unit (AIRO-01)Cro, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202510
FIG. 1 — Lineage of K041154, 1984–2025Source: 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 BTA? 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 BTA device

  1. #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (3)

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
*K952632S-Scort
Summary page 1
…ered Portable Aspiration Pump Classification name: Powered Suction Pump (21 CFR, 878.4780) Legally Marketed devices: The SSCOR, Inc. S-SCORTO TEN Model 2100, 510(k) K952632, cleared on June 16, 1995; The SSCOR, Inc. S-SCORTO Duet Model 2014, 510(…
Sscor1995—
*K945929S-Scort (R)Duet Model 2014 Portable Suction Pump
Summary page 1
…SCORTO TEN Model 2100, 510(k) K952632, cleared on June 16, 1995; The SSCOR, Inc. S-SCORTO Duet Model 2014, 510(k) K945929, cleared on December 22, 1994; Laerdal Medical Corp., Laerdal'T m Suct…
Sscor19941
*K840110Laerdal Suction Unit
Summary page 1
…el 2014, 510(k) K945929, cleared on December 22, 1994; Laerdal Medical Corp., Laerdal'T m Suction Unit, 510(k) K840110, cleared on March 12, 1984. Legally Marketed General Device Description: The S-SCORT® TEN battery p…
Laerdal Medical Corp.1984—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K153459TacvacAthena Gtx20161
K251101AIRO Suction Unit (AIRO-01)Cro, LLC20250

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K153459 (Athena Gtx, 2016) has gone furthest, with 1 descendant of its own.

How does its category compare?

All BTA devices

BTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTA

7so far in 2026, the most since 2007

2007: 12008: 32009: 22010: 22011: 12012: 12013: 32014: 32016: 32017: 12018: 42020: 12021: 12022: 32023: 42024: 52025: 62026 (partial year): 7
2007high 7 (2026) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTA

87in 2025

2008: 135 days median2013: 45 days median2014: 91 days median2016: 149 days median2018: 125 days median2022: 58 days median2023: 265 days median2024: 131 days median2025: 87 days median2026 (partial year): 89 days median
2007high 265 (2023) · low 45 (2013)2026

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

Recalls per year · BTA

1in 2021

2007: 12008: 32010: 32021: 1
2007high 3 (2008) · low 0 (2009)2026

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

Adverse event reports per year · BTA

13in 2025

2007: 132008: 52009: 142010: 1782011: 622012: 472013: 182014: 3992015: 152016: 252017: 42018: 172019: 142020: 102021: 92022: 72023: 82024: 132025: 13
2007high 399 (2014) · low 4 (2017)2025

MAUDE reports naming product code BTA, 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
20071—113
2008313535
20092—014
20102—3178
20111—062
20121—047
2013345018
20143910399
20150—015
20163149025
20171—04
20184125017
20190—014
20201—010
20211—19
202235807
2023426508
20245131013
2025687013
20267890—

What is it indicated for?

The S-SCORT...Jr® Quickdraw, Model 2400 portable battery powered suction pump is a non-sterile reusable device, with a non-sterile single use disposable canister and integrated suction tip, that is to be used by professional personnel trained in Emergency Care techniques of constant suctioning to clear the airway by removing bodily fluids and particulate matter.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K041154: S-Scort...JR Quickdraw, Model 2400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041154

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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