{
  "format": "devicerts.device.v1",
  "cite_as": "Patient Safe Luer Cap, Retractable Technologies, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/patient-safe-luer-cap-fmf (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/patient-safe-luer-cap-fmf",
    "json_url": "https://devicerts.com/devices/patient-safe-luer-cap-fmf.json",
    "markdown_url": "https://devicerts.com/devices/patient-safe-luer-cap-fmf.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/patient-safe-luer-cap-fmf",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Patient Safe Luer Cap",
    "registry_name": "PATIENT SAFE LUER CAP",
    "url": "https://devicerts.com/devices/patient-safe-luer-cap-fmf",
    "manufacturer": {
      "name": "Retractable Technologies, Inc.",
      "url": "https://devicerts.com/manufacturers/retractable-technologies-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K101708",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "FMF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Patient Safe Luer Cap is a Luer Lock Cap designed to reduce touch contamination and prevent medication leakage during use. It is intended for attachment to luer-tip syringes and other compatible devices to enhance aseptic technique and improve safety in clinical settings. Constructed to maintain sterility and minimize exposure risks, it aligns with standards for syringe accessories in healthcare environments.\n\nThis device is supplied as a single-use item and is intended for use in general hospital settings. It is not classified as MRI-safe or reusable, and no specific sterility assurance beyond standard manufacturing controls is stated. The cap is available in a single reference code, M-826, and must be stored according to manufacturer guidelines to preserve its integrity. Its regulatory status includes FDA 510(k) clearance (K101708) under the Traditional 510(k) Review pathway, with no third-party involvement.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K101708",
      "number_label": null,
      "device_udi_di": null,
      "date": "2011-02-24",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K101708",
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            }
          ]
        },
        {
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            {
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            }
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        }
      ]
    },
    {
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        {
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 880.5860",
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "General Hospital",
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            }
          ]
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          ]
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    }
  ]
}