510(k) Report

510(k) · Cleared

Cleared

Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation

K000266510(k) TraditionalCleared Jul 12, 2001531-day reviewClass II21 CFR 880.6740

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

Primary Care Solutions, Inc. · JOL Catheter And Tip, Suction

Cleared on Jul 12, 2001 after a 531-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided
Jul 12, 2001
Review
531 days
Class
Class II
Product code
JOL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2022: 1 descendant cleared2014: 1 descendant cleared2009: 1 descendant cleared2016: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK000266 Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for…Primary Care Solutions, Inc. · 2001
  2. Descendant · cites it directly · 7 of its ownK082330 Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc. · 2008
  3. Descendant · 2 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
  4. Descendant · 3 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
  5. Descendant · 4 generations on · 1 of its ownK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
  6. Descendant · 2 generations on · 1 of its ownK090848 Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc. · 2009

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12014: 12016: 12017: 12022: 12023: 12025: 1
2008high 1 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K082330Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc. · 2008 · cites it directly7descendants
  • K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 2 generations on4descendants
  • K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 3 generations on3descendants
  • K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023 · 4 generations on1descendant
  • K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc. · 2009 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000266Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device IrrigationPrimary Care Solutions, Inc.2001—
+1K082330Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc.2008—
+2K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences2014—
+3K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences2016—
+4K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.2023—
+2K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201410
201610
201710
202210
202310
202510
FIG. 1 — Lineage of K000266, 2001–2025Source: 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 JOL? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K082330Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc.20087

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, K082330 (Primary Care Solutions, Inc., 2008) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JOL devices

JOL Catheter And Tip, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOL

FDA has decided no JOL device since 2007.

Median 510(k) review, days · JOL

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

Recalls per year · JOL

1in 2023

2012: 12019: 32023: 1, 1 Class I2026 (partial year): 1
2007high 3 (2019) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · JOL

277in 2025

2007: 172008: 142009: 172010: 252011: 172012: 252013: 342014: 422015: 272016: 612017: 1812018: 1612019: 4422020: 1872021: 2832022: 2212023: 1972024: 2772025: 277
2007high 442 (2019) · low 14 (2008)2025

MAUDE reports naming product code JOL, 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—017
20080—014
20090—017
20100—025
20110—017
20120—125
20130—034
20140—042
20150—027
20160—061
20170—0181
20180—0161
20190—3442
20200—0187
20210—0283
20220—0221
20230—1 (1)197
20240—0277
20250—0277
20260—1—

More from Primary Care Solutions, Inc.

4 FDA decisions under this applicant name. See the company

  • K082330Primary Care Solutions, Inc., Sterile Water and Saline for IrrigationPrimary Care Solutions, Inc. · 2008
  • K030813Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog…Primary Care Solutions, Inc. · 20032 Class I recalls
  • K000265Primary Care Solutions Sterile Water Device IrrigationPrimary Care Solutions, Inc. · 2001

Recent decisions in JOL

The JOL category page

  • K051370Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014Baxter Healthcare Corp · 2005
  • K000265Primary Care Solutions Sterile Water Device IrrigationPrimary Care Solutions, Inc. · 2001
  • K003402Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device IrrigationWelcon, Inc. · 2001
  • K994321Sterile Water and 0.9% Sodium Chloride for Irrigation, UspAutomatic Liquid Packaging, Inc. · 2000
  • K974758Hydrox Sterile Water 4 OZ. Cup 120 ML., Hydrox Sterile Water 100 ML BottleHydrox Laboratories · 1998

https://510kreport.com/device/K000266 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000266: Primary Care Solutions Sterile Saline-0.9% Sodium Chloride for Device Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000266

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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