Respironics, Inc.: FDA filings under this applicant name

FDA lists 173 510(k) clearances under the applicant name “Respironics, Inc.” (first 1977, latest 2024), across 42 product codes in 9 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 155 days, against 207 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Philips, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Respironics, Inc. took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 207 days.

Top product codes

Plus 32 more product codes.

Review panels

• Anesthesiology (155)
• Neurology (7)
• Clinical Chemistry (2)
• Cardiovascular (2)
• Dental (2)
• Ear, Nose and Throat (2)
• Gastroenterology and Urology (1)
• General Hospital (1)
• Physical Medicine (1)

Most recent Respironics, Inc. 510(k) clearances

163 earlier clearances. See the full list in Caduvo.

Recalls

54 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2012-04-27.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Respironics, Inc. (a text match, not an official crosswalk):

• G0379 — Direct admission of patient for hospital observation care (via CAF)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Respironics Inc., Sleep & Home Respiratory Group (21 510(k)s)
• Respironics California, Inc. (11 510(k)s)
• Respironics Novametrix, Inc. (11 510(k)s)
• Respironics New Jersey, Inc. (5 510(k)s)
• Respironics Georgia, Inc. (2 510(k)s)
• Respironics Healthscan, Inc. (2 510(k)s)
• Respironics Respiratory Drug Delivery (Uk) , Ltd. (2 510(k)s)
• Respironics Inc. (Dba Philips Respironics) (1 510(k)s)
• Respironics (Ireland) Limited (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Respironics, Inc.?

FDA lists 173 510(k) clearances under the applicant name “Respironics, Inc.” (first 1977, latest 2024), across 42 product codes in 9 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Respironics, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Respironics, Inc. is 90 days. Since 2017: 155 days, versus 207 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Respironics, Inc.?

The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 67); CBK (Ventilator, Continuous, Facility Use, 14); MNS (Ventilator, Continuous, Non-Life-Supporting, 12).

Next steps

• See all 173 Respironics, Inc. clearances with predicates and recalls
• Run predicate analysis for product code BZD, Respironics, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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